Pure cut vs. Endocut in endoscopic biliary sphincterotomy: Systematic review and meta-analysis of randomized clinical trials

Abstract

Background and study aims Biliary sphincterotomy is a crucial step in endoscopic retrograde cholangiopancreatography (ERCP), a procedure known to carry a 5% to 10% risk of complications. The relationship between Pure cut, Endocut, post-ERCP pancreatitis (PEP) and bleeding is unclear. This systematic review and meta-analysis compared these two current types and their relationships with adverse events.

Patients and methods This systematic review involved searching articles in multiple databases until August 2023 comparing pure cut versus Endocut in biliary sphincterotomy. The meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).

Results A total of 987 patients from four randomized controlled trials were included. Overall pancreatitis: A higher risk of pancreatitis was found in the Endocut group than in the Pure cut group (P=0.001, RD=0.04 [range, 0.01 to 0.06]; I²=29%). Overall immediate bleeding: Statistical significance was found to favor Endocut, (P=0.05; RD=–0.15 [range, –0.29 to –0.00]; I²=93%). No statistical significance between current modes was found in immediate bleeding without endoscopic intervention (P=0.10; RD=–0.13 [range, –0.29 to 0.02]; I²=88%), immediate bleeding with endoscopic intervention (P=0.06; RD=–0.07 [range, –0.14 to 0.00]; I²=76%), delayed bleeding (P=0.40; RD=0.01 [range, –0.02 to 0.05]; I²=72%), zipper cut (P=0.58; RD=–0.03 [range, –0.16 to 0.09]; I²=97%), perforation (P=1.00; RD=0.00 [range, –0.01 to 0.01]; I²=0%) and cholangitis (P=0.77; RD=0.00 [range, –0.01 to 0.02]; I²=29%).

Conclusions The available data in the literature show that Endocut carries an increased risk for PEP and does not prevent delayed or clinically significant bleeding, although it prevents intraprocedural bleeding. Based on such findings, Pure cut should be the preferred electric current mode for biliary sphincterotomy.

Keywords

Pancreatobiliary (ERCP/PTCD) - ERC topics - Stones

Introduction

Endoscopic biliary sphincterotomy is a crucial step in endoscopic retrograde cholangiopancreatography (ERCP), a procedure known to carry a 5% to 10% risk of complications, including post-ERCP pancreatitis (PEP), bleeding, cholangitis, perforation, sepsis, and even death [1] [2] [3] [4] [5]. Two commonly used current modes in sphincterotomy are Pure cut and Endocut (or pulsed cut) [6] [7] [8].

Pure cut utilizes a pure sine wave with high frequency and lower voltage, with arcs that have a voltage higher than 200 volts and are generated as soon as vaporization of liquid in the tissue creates a small gap between the cutting wire and tissue in the duodenal papilla (ERBE Elektromedizin GmbH. Endo CUT I. Tubingen: ERBE; 2016). Endocut (types 2 or 3) uses coagulation between the cutting cycles. Coagulation presents a very short active sinus wave (6% to 10% of cycle) with a more extended cooling period (inactivated 90%-94% of cycle, lasting 720–750 ms) [9] [10] [11] [12]. Therefore, in this text, Endocut refers to types 2 and 3.

Thermal injury from the coagulation effect of Endocut can lead to local edema in the major papilla, potentially impairing pancreatic duct drainage and predisposing PEP, as some studies suggest [11] [12] [13] [14]. However, the most recent meta-analysis by Funari et al. did not find statistical evidence supporting this claim [15]. On the other hand, Endocut has been shown to decrease intraprocedural bleeding, likely due to its coagulation effect [11] [12]. However, previous studies did not show that Endocut is capable of reducing delayed bleeding with clinical repercussions [15] [16].

Thus, the primary objective of our study was to compare these two current modes (pure cut and Endocut) considering post-ERCP adverse events (AEs), especially PEP and bleeding. Therefore, we intended to investigate whether the available literature could support selection of the optimal current mode during biliary sphincterotomy, ultimately enhancing patient safety and clinical outcomes related to this procedure.

Patients and methods

Protocol and registration

The research was carried out following the PRISMA flow diagram ([Fig. 1]), guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) and registered in PROSPERO (International Prospective Register of Systematic Reviews) under the registration number CRD42023458386 [17] [18].

Fig. 1 PRISMA flow diagram.

Eligibility criteria

Only randomized clinical trials (RCTs) comparing pure cut and Endocut modes for endoscopic biliary sphincterotomy were eligible for inclusion. The exclusion criteria were as follows: studies that discussed any current mode other than Endocut or pure cut, patients younger than age 18 years, animal studies, retrospective studies, and patients with significant anatomical alterations (e.g., Roux-en-Y and Billroth II).

Search strategy, study selection and data collection process

For this meta-analysis, a comprehensive search was conducted independently by two authors (LBO and MPF) across multiple databases, including Medline, Embase, Lilacs, Central Cochrane, and Google Scholar, spanning from inception until June 2023. The search process involved meticulously reviewing all titles within these databases, removing any duplicate entries. Subsequently, articles that did not meet the predetermined inclusion criteria were excluded. In the second phase, all abstracts of the remaining articles were thoroughly assessed. From this selection, both reviewers cross-referenced the results to ensure accuracy. In cases where there was uncertainty or disagreement between the reviewers, a third reviewer (ASTK) was consulted to reach a consensus. To facilitate data extraction, the researchers utilized standardized Excel spreadsheets to record information related to the dichotomous outcomes, including pancreatitis and its grades, intraprocedural bleeding with and without the need for endoscopic intervention, delayed bleeding, uncontrolled sphincterotomy, perforation, and cholangitis [1].

Search strategy

Keywords for the strategy search for PubMed (Medline) were papillotomy, sphincterotomy, retrograde cholangiopancreatography, endoscopic, cut, blend and Endocut. The full strategy:

(((((papillotomy OR Sphincterotomy OR Sphincterotomies OR Sphincterotome OR Sphincteroplasty OR Sphincteroplasties) OR ((Retrograde Cholangiopancreatography, Endoscopic OR Cholangiopancreatographies, Endoscopic Retrograde OR Endoscopic Retrograde Cholangiopancreatographies OR Retrograde Cholangiopancreatographies, Endoscopic OR Endoscopic Retrograde Cholangiopancreatography OR ERCP) AND (cut OR electrosurg* OR knife OR blend OR electric* OR blend OR electrocautery OR cautery OR coagulation OR endocut)))))).

Data analysis

All outcomes were assessed by dichotomous variables using the Mantel-Haenszel test to determine risk differences. We used a confidence interval (CI) of 95% and a significant P < 0.05. We preferred to apply CI rather than prediction interval because the Cochrane Handbook for Systematic Reviews of Interventions explicitly states that a minimum of 10 studies is typically recommended for application of prediction intervals, and in our meta-analysis, we had a total of four studies. Nevertheless, CI was used in other recent meta-analyses on this topic [15] [16]. We assessed the heterogeneity of the forest plot by the Higgins test (I²). If I² is 0% to 40%, the heterogeneity might not be significant; if 30% to 60%, the results may represent substantial heterogeneity; and if 75% to 100%, they represent considerable heterogeneity [19]. A sensitivity analysis was performed utilizing a funnel plot to identify potential outliers.

If exclusion of specific studies from the meta-analysis resulted in a homogenous dataset, those studies were considered true outliers and permanently excluded. In such cases, the fixed-effect model was employed for the final analysis. However, if no outliers were identified or if heterogeneity remained high despite excluding outliers, we opted for the random-effects model. This approach helps mitigate the impact of heterogeneity on the overall findings, ensuring a more robust and reliable conclusion.

In the case of moderate or high heterogeneity, if I²>50%, the random-effects model was used. Otherwise, in the case of low heterogeneity, I² <50%, and the fixed-effects test was performed. All direct analyses were carried out in RevMan 5 software (Review Manager version 5.4.1—Cochrane Collaboration Copyright) [20].

Methodology quality and risk of bias in individual studies

To comprehensively assess the overall quality of each outcome analysis and the respective RCTs, we followed the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) standards [21], utilizing GRADEpro software for guideline development tools (GRADEpro Guideline Development Tool [Software]. McMaster University and Evidence Prime, 2022).

Biases present in the selected RCTs were carefully assessed using the Cochrane Risk of Bias Tool (Rob2) ([Fig. 2]) [22]. Evaluation of study quality encompassed patient selection, comparability of the study groups, and outcome measures. Each RCT was meticulously analyzed using RoB 2, focusing on aspects such as randomization and allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), handling of incomplete outcome data (attrition bias), adherence to outcome and prognostic factors, intention-to-treat analysis, sample size calculation, and selective reporting.

Fig. 2 Risk of Bias 2 (RoB 2) tool.

To ensure consistency and accuracy in bias assessment using RoB 2 and the GRADE analysis, two independent reviewers (LBO and MPF) conducted the evaluations. In instances of disagreements, a third reviewer (ASTK) was consulted to achieve a consensus and ensure the reliability of the findings.

Outcome definitions

There is no standardized graduation for immediate (intraprocedural) bleeding, and the included studies use different definitions. To homogenize this analysis, we classified the study definitions into either self-limited bleeding or bleeding with the need for endoscopic intervention. Delayed bleeding was defined and graded according to the Cotton criteria [23].

For meta-analysis purposes, we only considered perforations related to biliary sphincterotomy, classified as Stapfer II [24].

PEP was defined according to Cotton’s criteria because Funari, Norton, and Kida mentioned Cotton’s classification. Ellahi mentioned “according to a consensus definition.” However, we considered Cotton because this was an abstract from 2001, and at that time, Cotton’s criteria were the only classification in this theme (created in 1991), while Atlanta's Classification was developed in 2012 [23].

In this review all AEs described in the studies in question are mentioned. However, our focus will be on more in-depth exploration of procedure-related AEs, which are notably prevalent in this context. Specifically, we delve into issues such as pancreatitis, bleeding, perforation, zipper cut, and cholangitis—areas of particular interest to us. Consequently, when we reference AEs in this review, we are specifically alluding to those previously mentioned.

Results

Study selection and characteristics of included studies

A total of 24,588 studies were found in the systematic review. After screening, six articles were selected for full-text analysis. After applying the eligibility criteria, four studies were included in the meta-analysis ([Table 1]).

Table 1 Details of included studies.

Study	N	Compared groups	ERCP indication	Electrosurgical unit	Age (mean)	Gender (M/F)	Outcomes
ERCP, endoscopic retrograde cholangiopancreatography; SOD, sphincter of Oddi; PSC, primary sclerosing cholangitis.
Funari, 2023 (fully published article)	550	Endocut (278)	Choledocholithiasis, stenosis (benign and malignant), fistula, others	ERBE VIO 300 and ERBE VIO 3 Endocut I, effect 2, cutting duration 3, cutting interval 3	52,84	60%	Pancreatitis: 9 mild; 3 moderate; 0 severe; Immediate bleeding: 35 (total); Immediate bleeding (E. I.): 12 Immediate bleeding (N.I.): 23 Delayed Bleeding: 12 Cholangitis: 2 (total); Perforation: 0 (total);
		Pure cut (272)		WEM SS-200E pure cut 30–50 W (WEM/Medtronic, Minneapolis, Minnesota, United States) and ERBE ICC 200 (ERBE Elektromedizin, Tübingen, Germany) 3, 30–50 W		39%	Pancreatitis: 3 mild; 1 moderate; 0 severe; Immediate bleeding: 66 (total); Immediate bleeding (E. I.): 39 Immediate bleeding (N.I.): 27 Delayed Bleeding: 4 Cholangitis: 0 (total); Perforation: 0 (total);
Norton, 2005 (fully published article)	267	Endocut (134)	Choledocholithiasis, stenosis (benign and malignant), SOD, PSC	Erbe ICC200 (Erbe, Marietta, Georgia, United States) 150-W	59 (19–99)	47%	Pancreatitis: 1 mild; 2 moderate, 0 severe. Immediate bleeding: 8 Immediate bleeding (E. I.): 4 Immediate bleeding (N.I.): 8 Delayed Bleeding: 0 Perforation: 0 (total)
		Pure cut (133)		Valleylab ForceEZ 60-W on the Low Coag-3 setting		51%	Pancreatitis: 1 mild; 0 moderate, 0 severe. Immediate bleeding: 35 Immediate bleeding (E. I.): 6 Immediate bleeding (N.I.): 35 Delayed Bleeding: 0 Perforation: 0 (total)
Kida, 2004 (abstract)	84	Endocut (41)	Choledocholithiasis, malignant strictures, others	No information	66,2	53%	Pancreatitis: 4 (total) Immediate bleeding: 13 Immediate bleeding (E. I.): 1 Immediate bleeding (N.I.): 12 Perforation: 0 (total)
		Pure cut (43)		No information		47%	Pancreatitis: 1 (total) Immediate bleeding: 28 Immediate bleeding (E. I.): 6 Immediate bleeding (N.I.): 22 Perforation: 0 (total)
Ellahi, 2001 (abstract)	86	Endocut (55)	Choledocholithiasis, SOD, obstructive jaundice and pancreatitis	No information	NR	Unclear	Pancreatitis: 1 mild; 3 moderate; 1 severe; Immediate bleeding: 0 (total) Cholangitis: 1 (total) Perforation: 1 (total)
		Pure cut (31)		No information			Pancreatitis: 0 mild; 0 moderate; 0 severe; Immediate bleeding:0 (total) Cholangitis: 1 (total) Perforation: 0 (total)

Two studies were RCTs and two were congress abstracts. Most studies indicated choledocholithiasis, stenosis (benign and malignant), and dysfunction of Oddi’s sphincter (SOD). Patients were on average 59 years old of both genders (basically 50% of each). More details about the included studies are summarized in [Table 1].

Methodology quality and risk of bias

The quality of evidence for each outcome analysis evaluated by GRADE is shown in [Table 2] and the risk of bias in all the included studies is described in [Table 1].

Table 2 GRADEpro guideline development tool.

Certainty assessment							Number of patients		Effect		Certainty	Importance
№ of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Pure cut	Endocut	Relative (95% CI)	Absolute (95% CI)
CI, confidence interval. *According RoB 2. † 50% < I² < 75%. ‡Ratio of confidence interval by standard deviation > 2. §Ratio of confidence interval by standard deviation >3. ¶i² >75%. **There is a lack of information about the definition of bleeding (grades and time it happened). ††There is a lack of information about the definition for bleeding.
Pancreatitis
4	Randomized trials	Serious*	Not serious	Not serious	Not serious	Strong association all plausible residual confounding would reduce the demonstrated effect	28/507 (5.5%)	8/480 (1.7%)	Not estimable	40 fewer per 1.000 (from 60 fewer to 10 fewer)	⊕⊕⊕⊕ High	CRITICAL
Mild pancreatitis
4	Randomized trials	Serious*	Serious†	Serious‡	Serious‡	Strong association all plausible residual confounding would reduce the demonstrated effect	24/507 (4.7%)	9/480 (1.9%)	Not estimable	20 fewer per 1.000 (from 50 fewer to 10 more)	⊕⊕○○ Low	CRITICAL
Moderate pancreatitis
4	Randomized trials	Serious*	Not serious	Not serious	Serious‡	Strong association all plausible residual confounding would reduce the demonstrated effect	7/507 (1.4%)	1/480 (0.2%)	Not estimable	10 fewer per 1.000 (from 20 fewer to 0 fewer)	⊕⊕⊕⊕ High	IMPORTANT
Severe pancreatitis
4	Randomized trials	Serious*	Serious†	Not serious	Very serious§	Strong association all plausible residual confounding would reduce the demonstrated effect	7/507 (1.4%)	1/480 (0.2%)	Not estimable	0 fewer per 1.000 (from 20 fewer to 10 more)	⊕⊕○○ Low	IMPORTANTE
Overall immediate bleeding
4	Randomized trials	Serious	Very serious	Not serious	Not serious	None	56/507 (11.0%)	129/480 (26.9%)	Not estimable	150 more per 1.000 (from 0 fewer to 290 more)	⊕○○○ Very low	CRITICAL
Immediate bleeding (no endoscopic intervention)
3	Randomized trials	Serious*,**	Very serious	Serious††	Not serious	Strong association	43/452 (9.5%)	84/449 (18.7%)	Not estimable	130 more per 1.000 (from 20 fewer to 290 more)	⊕○○○ Very low	NOT IMPORTANT
Immediate bleeding (with endoscopic intervention)
3	Randomized trials	Serious*,**	Very serious	Not serious	Seriousc	None	17/452 (3.8%)	51/449 (11.4%)	Not estimable	70 more per 1.000 (from 0 fewer to 140 more)	⊕○○○ Very low	IMPORTANT
Delayed bleeding
3	Randomized trials	Serious*,**	Not serious	Serious**	Very serious§	Strong association	13/466 (2.8%)	4/437 (0.9%)	Not estimable	10 fewer per 1.000 (from 50 fewer to 20 more)	⊕○○○ Very low	CRITICAL
Perforation
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	Strong association all plausible residual confounding would suggest spurious effect, while no effect was observed	0/452 (0.0%)	0/134 (0.0%)	Not estimable	0 fewer per 1.000 (from 10 fewer to 10 fewer)	⊕⊕⊕⊕ High	CRITICAL
Zipper cut
3	Randomized trials	Serious*	Very serious	Not serious	Not serious	Strong association	0/452 (0.0%)	12/449 (2.7%)	Not estimable	30 more per 1.000 (from 90 fewer to 160 more)	⊕⊕○○ Low	IMPORTANT
Cholangitis
2	Randomized trials	Serious	Not serious	Not serious	Very serious§	All plausible residual confounding would suggest spurious effect, while no effect was observed	2/333 (0.6%)	1/303 (0.3%)	Not estimable	0 fewer per 1.000 (from 20 fewer to 10 more)	⊕⊕○○ Low	NOT IMPORTANT

Metanalysis

Mild pancreatitis

Four articles analyzing mild pancreatitis were included, totaling 987 patients. No statistical significance was identified with the current mode (P=0.20; RD=0.02 [-0.01, 0.05]; I² = 56%) as shown in [Fig. 3]. The GRADEpro tool showed a low level of certainty.

Fig. 3 Forest plot for mild pancreatitis.

Moderate pancreatitis

Four articles were included in this outcome, totaling 987 patients, with no statistical significance association with the current mode (P=0.10; RD=0.01 [–0.00, 0.02]; I²=0%) as shown in [Fig. 4]. The GRADEpro tool showed a high level of certainty.

Fig. 4 Forest plot for moderate pancreatitis.

Severe pancreatitis

Four articles were included in this outcome, totaling 987 patients. No statistically significant association with the current mode was observed (P=0.70; RD=0.00 [range –0.01–0.02]; I²=60%) as shown in [Fig. 5]. The GRADEpro tool showed a low certainty level and high bias risk. It presented severe imprecision and high magnitude.

Fig. 5 Forest plot for severe pancreatitis.

Overall pancreatitis

Four articles were included in the evaluation of overall pancreatitis, with a total of 987 patients. A higher risk of pancreatitis was found in the Endocut group than in the pure cut group (P=0.001, RD=0.04 [range 0.01–0.06]; I²=29%) as shown in [Fig. 6]. The GRADE pro tool showed a high level of certainty. The number needed to treat (NNT) was 25.

Fig. 6 Forest plot for pancreatitis in general.

Immediate bleeding (no endoscopic intervention)

Three articles were included in this outcome, totaling 901 patients. The synthesis showed no statistical significance between current modes (P=0.10; RD=–0.13 [range –0.29–0.02]; I²=88%), as indicated in [Fig. 7]. The GRADEpro tool showed a very low level of certainty and high heterogeneity (I²=88%). This outcome presented a high risk of bias.

Fig. 7 Forest plot for immediate bleeding (no endoscopic intervention).

Immediate bleeding (with endoscopic intervention)

Three articles were included in this outcome, totaling 901 patients. The synthesis demonstrated no statistical significance for risk of bleeding requiring endoscopic intervention between groups (P=0.06; RD=–0.07 [range –0.14–0,00]; I²=76%), as shown in [Fig. 8]. The GRADEpro tool showed a very low level of certainty, high heterogeneity (I²=76%), and high risk of bias.

Fig. 8 Forest plot for immediate bleeding (with endoscopic intervention).

Overall immediate bleeding

Four articles were included in this outcome, totaling 987 patients. The summary effect showed a statistical significance between pure cut and Endocut concerning overall immediate bleeding (P=0.05; RD=–0.15 [range –0.29 to –0.00]; I²=93%), as shown in [Fig. 9]. The GRADEpro tool shows a very low level of certainty, high heterogeneity (i²=93%) and high risk of bias. The NNT was 6.66.

Fig. 9 Forest plot for overall immediate bleeding.

Delayed bleeding

Three studies were included in this outcome, totaling 903 patients. No statistical significance was found (P=0.40; RD=0.01 [range –0.02–0.05]; I²=72%), as shown in [Fig. 10]. The GRADEpro tool presented very low certainty, high level of heterogeneity, and low level of bias.

Fig. 10 Forest plot for delayed bleeding.

Zipper cut sphincterotomy

Three articles were included in this outcome, totaling 896 patients. No statistical significance was found (P=0.58; RD=–0.03 [range –0.16–0.09]; I²=97%). The GRADEpro tool considered the level of certainty very low, low inconsistency, and high risk of bias.

Perforation

Three studies were included in this outcome, totaling 901 patients. No statistical significance was found concerning perforation rates (P=1.00; RD=0.00 [range –0.01–0.01]; I²=0%). The GRADEpro tool presented a high level of certainty, low level of heterogeneity, and high risk of bias.

Cholangitis

Two articles were included in this outcome, totaling 636 patients. No statistical significance was found (P=0.77; RD=0.00 [range –0.01–0.02]; I²=29%). The GRADEpro tool considered a low level of certainty, very serious inconsistency, and high risk of bias.

Discussion

To date, this is the fourth meta-analysis comparing Endocut and Pure cut for sphincterotomies but the only one to include all four currently available RCTs. The three previously published meta-analyses (Hedjoudje 2021, Funari 2018, Verma 2007) demonstrated similar results: lower rates of immediate bleeding with pure cut and no difference for PEP, delayed bleeding, and other AEs [15] [16] [25] [26]. Based on such findings, an important recent guideline recommends using Endocut to perform sphincterotomies [12].

It is important to emphasize that the studies used different types of electrical surgery units that influence electric power and details of the type of coagulation. This is because they were performed in different countries and years, so they cannot be homogeneous. However, the most frequent and concerning post-ERCP AE is PEP. The recent publication of a large RCT has made us hypothesize that Endocut is a risk factor for PEP, which corroborates the principles of electrosurgery [12] [27] [28] [29]. Theoretically, local edema due to pronounced thermal injury from the coagulation modes could obstruct the pancreatic duct, favoring PEP. Our results confirm this assumption. Nevertheless, it is unclear whether associated measures, such as use of rectal nonsteroidal anti-inflammatory drugs (NSAID), could further enhance the protective effect of Pure cut or if moderate and severe pancreatitis could also be reduced.

Immediate bleeding with the need for endoscopic intervention during the index ERCP seems to have a trend in favor of Endocut. This result corroborates the aforementioned meta-analyses [7] [8] [29]. Notably, however, the reported intraprocedural bleeding had no clinical repercussions, and in all cases it was controlled during the same procedure.

Delayed bleeding was also no different between groups. Some studies have suggested that increased intraprocedural bleeding might be a risk factor for delayed bleeding; however, the extensive series and our results did not corroborate this finding [15] [27] [29] [30]. We speculate that Pure cut allows for a cleaner cut, which increases the chance of identifying and immediately treating bleeding vessels during ERCP. Ultimately, immediate hemostatic control would prevent delayed bleeding. Therefore, Endocut should not be considered a measure to prevent bleeding with clinical repercussions.

Some authors consider Endocut to be safer in terms of uncontrolled sphincterotomy (zipper cut) and sphincterotomy-related perforation [31] [32]. However, our results did not support such a rationale. Regardless, one should note that Pure cut must be used cautiously (quick steps on the pedal activating the electrosurgical unit) to prevent endoscopists from gaining control of the cut, because the generator does not interrupt the cutting cycle automatically [12] [27] [33]. Furthermore, zipper cut and perforation are strongly influenced by other technical factors related to endoscopist experience, which should be considered.

Our study is not exempt from limitations, as inclusion of abstracts was part of our analysis. However, we decided to include those studies because they provided all the essential information to fulfill our eligibility criteria, enabling our analysis. Another limitation is the lack of definition and differentiation between types of immediate bleeding, which was mitigated. We tried to mitigate this by differentiating self-limited from bleeding with the need for endoscopic intervention. Similarly with delayed bleeding follow-up, which was not mentioned in one of the three articles being analyzed in this variable (Ellahi et al), we agreed to consider 7 days. In addition, more than two decades separate the first and last eligible published study, and only the latest study employed the modern electrosurgical settings and generator for the Endocut mode [12] [32]. Furthermore, although the benefits of prophylactic NSAIDs for preventing PEP are well known, none of the included studies employed them [34] [35] [36]. Only one of the included studies used hyperhydration with lactated Ringer’s solution as a preventive measure [37] [38]. Therefore, new studies are warranted to elucidate the effect of overlapping measures in prevention of PEP. Also, endoscopist experience influences the precision of biliary sphincterotomy, reflecting incidence of AEs. However, these data are not detailed in some of the studies [39].

It is important to emphasize that the Endocut effect does not necessarily promote the coagulation effect between the cutting cycles. This term refers specifically to an automatically controlled pure cut with predetermined interruptions [12]. Starting at effect 2 and above effects, this modality includes coagulation modes between cutting cycles. All included studies used the equivalent to effect 2 or higher, reinforcing the role of thermal injury in PEP pathophysiology. Consequently, Endocut effect 1 is an option to use pure cut in a more controlled and safer manner [39].

All figures were generated by the programs mentioned in methods such as RevMan 5 software (all forest plots), risk of bias (RoB 2), and PRISMA guidelines (both PRISMA flow diagram and checklist) [17] [18] [20] [22] [40].

Conclusions

In conclusion, based on the discussion, it is possible to decrease PEP incidence with a pure cut without increased bleeding with clinical repercussions.

Conflict of Interest

Vitor Ottoboni Brunaldi: payment for lectures by Erbe Elektromedizin GmbH; Tomazo Antonio Prince Franzini: consultant to Boston Scientific; Eduardo Guimarães Hourneaux de Moura: consultant to Boston Scientific and Olympus; The remaining authors have no conflicts of interest to declare.

Acknowledgement

Mateus Pereira Funari: I thank Dr. Mateus for help with collecting data, discussion and advice about the manuscript. Angelo So Taa Kum: I thank Dr. Angelo for help with text research and technical assistance. Alexandre Moraes Bestetti: I thank Dr. Alexandre for help with text research and technical assistance. Vitor Ottoboni Brunaldi: I thank Dr. Vitor for advice about the draft and language corrections. Tomazo Antonio Prince Franzini: I thank Dr. Tomazo for corrections made to the manuscript. Eduardo Turiani Hourneaux de Moura: I thank. Dr. Eduardo for corrections made to the manuscript. Luiza Martins Baroni: I thank Dr. Luiza for help with the collection process, discussion about statistical analysis and language corrections. Matheus Ferreira de Carvalho: I thank Dr. Matheus for help with the collection process, discussion about the statistical analysis and language corrections. Wanderley Marques Bernardo: I thank Dr. Wanderlay for help with statistical lessons and analysis. Eduardo Guimarães Hourneaux de Moura: I thank Dr. Eduardo for the opportunity to write about this theme, and for critiquing the manuscript.

• References

• 1 Thaker AM, Mosko JD, Berzin TM. Post-endoscopic retrograde cholangiopancreatography pancreatitis. Gastroenterol Rep (Oxf) 2015; 3: 32-40
• 2 de Clemente Junior CC, Bernardo WM, Franzini TP. et al. Comparison between endoscopic sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation for removal of bile duct stones: A systematic review and meta-analysis based on randomized controlled trial. World J Gastrointest Endosc 2018; 10: 130-144
• 3 Furuya CK, Sakai P, Marinho FRT. et al. Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial. World J Gastroenterol 2018; 24: 1803-1811
• 4 Kouanda A, Bayudan A, Hussain A. et al. Current state of biliary cannulation techniques during endoscopic retrograde cholangiopancreatography (ERCP): International survey study. Endosc Int Open 2023; 11: E588-E598
• 5 Ak Ç, Aykut H, Pala E. et al. Post-ERCP complication analysis of an experienced center. Surg Laparosc Endosc Percutan Tech 2022; 32: 707-713
• 6 Williams EJ, Taylor S, Fairclough P. et al. Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study. Endoscopy 2007; 39: 793-801
• 7 Andriulli A, Loperfido S, Napolitano G. et al. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781-1788
• 8 Güitrón-Cantú A, Adalid-Martínez R, Gutiérrez-Bermúdez JA. et al. Complications in diagnostic and therapeutic endoscopic cholangiopancreatography. Prospective study. Rev Gastroenterol Mex 2007; 72: 227-235
• 9 Marsano LS. Principles of Electrosurgery. https://louisville.edu/medicine/departments/medicine/dividions/gimedicine/physician-resources/lectures/procedures/electrocautery
• 10 Fukami N. Endoscopic submucosal dissection – principles and practice. New York: Springer; 2015
• 11 Ratani RS, Mills TN, Ainley CC. et al. Electrophysical factors influencing endoscopic sphincterotomy. Gastrointest Endosc 1999; 49: 43-52
• 12 Rey JF, Beilenhoff U, Neumann CS. et al. European Society of Gastrointestinal Endoscopy (ESGE) guideline: the use of electrosurgical units. Endoscopy 2010; 42: 764-772
• 13 Perini RF, Sadurski R, Cotton PB. et al. Post-sphincterotomy bleeding after the introduction of microprocessor-controlled electrosurgery: does the new technology make the difference. Gastrointest Endosc 2005; 61: 53-57
• 14 Curtiss LE. High frequency currents in endoscopy: a review of principles and precautions. Gastrointest Endosc 1973; 20: 9-12
• 15 Funari MP, Ribeiro IB, de Moura DTH. et al. Adverse events after biliary sphincterotomy: Does the electric current mode make a difference? A systematic review and meta-analysis of randomized controlled trials. Clin Res Hepatol Gastroenterol 2020; 44: 739-752
• 16 Verma D, Kapadia A, Adler DG. Pure versus mixed electrosurgical current for endoscopic biliary sphincterotomy: a meta-analysis of adverse outcomes. Gastrointest Endosc 2007; 66: 283-290
• 17 Page MJ, McKenzie JE, Bossuyt PM. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71
• 18 PROSPERO 2019. https://www.crd.york.ac.uk/PROSPERO/
• 19 Cochrane Handbook for Systematic Reviews of Interventions [Internet]. Cochrane.org.2019. https://www.training.cochrane.org/handbook
• 20 Review Manager (RevMan). Version 5. 4. 1. The Cochrane Collaboration, 21 09. 2020. https://revman.cochrane.org.
• 21 Gradepro.org. https://www.gradepro.org/terms/cite
• 22 Higgins JP, Altman DG, Gøtzsche PC. et al. Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928
• 23 Cotton PB, Lehman G, Vennes J. et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
• 24 Cirocchi R, Kelly MD, Griffiths EA. et al. A systematic review of the management and outcome of ERCP related duodenal perforations using a standardized classification system. Surgeon 2017; 15: 379-387
• 25 Li DF, Yang MF, Chang X. et al. Endocut versus conventional blended electrosurgical current for endoscopic biliary sphincterotomy: A meta-analysis of complications. Dig Dis Sci 2019; 64: 2088-2094
• 26 Pereira Funari M, Ottoboni Brunaldi V, Mendonça Proença I. et al. Pure cut or Endocut for biliary sphincterotomy? A multicenter randomized clinical trial. Am J Gastroenterol 2023; 118: 1871-1879
• 27 Norton ID, Petersen BT, Bosco J. et al. A randomized trial of endoscopic biliary sphincterotomy using pure-cut versus combined cut and coagulation waveforms. Clin Gastroenterol Hepatol 2005; 3: 1029-1033
• 28 Tsang HC, Lam CS, Chu PW. et al. A randomized controlled trial of auricular transcutaneous electrical nerve stimulation for managing posthysterectomy pain. Evid Based Complement Alternat Med 2011; 2011: 276769
• 29 Freeman ML, Nelson DB, Sherman S. et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996; 335: 909-918
• 30 Köksal AŞ, Eminler AT, Parlak E. Biliary endoscopic sphincterotomy: Techniques and complications. World J Clin Cases 2018; 6: 1073-1086
• 31 Testoni PA, Mariani A, Aabakken L. et al. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 657-683
• 32 Kim HJ, Kim MH, Kim DI. et al. Endoscopic hemostasis in sphincterotomy-induced hemorrhage: its efficacy and safety. Endoscopy 1999; 31: 431-436
• 33 Serrano JPR, de Moura DTH, Bernardo WM. et al. Nonsteroidal anti-inflammatory drugs versus placebo for post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and meta-analysis. Endosc Int Open 2019; 7: E477-E486
• 34 Akshintala VS, Sperna Weiland CJ, Bhullar FA. et al. Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol 2021; 6: 733-742
• 35 Thanage R, Jain S, Chandnani S. et al. Is the combination of rectal diclofenac and intravenous ringer lactate superior to individual therapy for prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: A prospective, open-label, single-center randomized trial. Pancreas 2021; 50: 1236-1342
• 36 Marín-Gabriel JC, Romito R, Guarner-Argente C. et al. Use of electrosurgical units in the endoscopic resection of gastrointestinal tumors. Gastroenterol Hepatol 2019; 42: 512-523
• 37 Puig I, Calvet X, Baylina M. et al. How and when should NSAIDs be used for preventing post-ERCP pancreatitis? A systematic review and meta-analysis. PLoS One 2014; 9: e92922
• 38 Chandrasekhara V, Khashab MA, Muthusamy VR. et al. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32-47
• 39 Jena A, Jain S, Sundaram S. et al. Electrosurgical unit in GI endoscopy: the proper settings for practice. Expert Rev Gastroenterol Hepatol 2023; 17: 825-835
• 40 Sterne JAC, Savović J, Page MJ. et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019; 366: l4898

Publikationsverlauf

Eingereicht: 22. Dezember 2023

Angenommen nach Revision: 12. April 2024

Accepted Manuscript online:
13. Mai 2024

Artikel online veröffentlicht:
03. Juli 2024