CLIP CLOSURE OF LARGE NON-PEDUNCULATED COLON POLYPS WITH AVERAGE AND HIGH RISK OF DELAYED BLEEDING

Aims:

The efficacy of clip closure (CC) of the mucosal defect after colonic endoscopic mucosal resection (EMR) to prevent a delayed bleeding (DB) is unclear. Previous studies included unselected cases with a wide range of DB risks. Our aim was to evaluate the efficacy of clip closure after EMR of large (>= 20 mm) non-pedunculated colon polyps (LNPCP) in selected cases with average or high risk of DB.

Methods:

Multicentre single blind randomised controlled clinical trial. The bleeding risk was established using a previous published score (Albeniz et al. CGH 2016). The inclusion criteria were consecutive cases of EMR of LNPCP>= 20 mm with average or high DB risk, defined as a score>= 4. A sample size of 200 cases of EMR of LNPCP>= 20 mm was estimated. The participants were randomised 1:1 to complete mucosal defect clip closure (CC) or control groups. The main outcome measure was the DB rate. The intention to treat (ITT) analysis included all randomised participants and the per protocol (PP) analysis included cases that achieved a complete mucosal closure.

Results:

A total of 210 cases were included in 11 hospitals (104 CC, 106 control). Both groups were comparable in terms of baseline characteristics. In the CC group, 54% achieved a complete closure, 31% partial closure and 15% failure to close. In the ITT analysis, DB risk was 11.3% vs. 5.8%, p = 0.15 in control and CC groups respectively. In the PP analysis, DB risk was 11.3% vs. 1.8%, p = 0.036 in control and CC groups respectively.

Conclusions:

Complete clip closure of the mucosal defect is effective to prevent a delayed bleeding after a large colonic endoscopic mucosal resection with average or high delayed bleeding risk.

However it is not possible to achieve a complete closure in roughly half of the cases due to the great size or the difficult localization.