Endoscopy 2008; 40(3): 184-191
DOI: 10.1055/s-2007-995426
Original article

© Georg Thieme Verlag KG Stuttgart · New York

Early closure of a multicenter randomized clinical trial of endoscopic stenting versus surgery for stage IV left-sided colorectal cancer

J.  E.  van Hooft1 , P.  Fockens1 , A.  W.  Marinelli2 , R.  Timmer3 , A.  M.  van Berkel4 , P.  M.  Bossuyt5 , W.  A.  Bemelman6 , on behalf of the Dutch Colorectal Stent Group[1]
  • 1Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands
  • 2Department of Surgery, Medical Center Haaglanden, Den Haag, The Netherlands
  • 3Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, The Netherlands
  • 4Department of Gastroenterology and Hepatology, Rode Kruis Hospital, Beverwijk, The Netherlands
  • 5Department of Clinical Epidemiology and Bio-statistics, Academic Medical Center, Amsterdam, The Netherlands
  • 6Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands
Further Information

Publication History

submitted 11 September 2007

accepted after revision 24 October 2007

Publication Date:
06 March 2008 (online)

Also available at
    Permissions and Reprints

See also:

Commentaire de travail de J. E. van Hooft et al., pp. 184Endoscopy 2008; 40(03): 355-355
DOI: 10.1055/s-0032-1306813

Background and study aims: The introduction of self-expandable metal stents has offered a promising alternative for palliation of malignant left-sided colonic obstruction. This randomized clinical trial aimed to assess whether a nonsurgical policy, with endoluminal stenting, is superior to surgical treatment in patients with stage IV left-sided colorectal cancer and imminent obstruction.Patients and methods: Patients with incurable left-sided colorectal cancer who fulfilled the study criteria were randomly assigned to nonsurgical or surgical treatment. The primary outcome measure was survival in good health out of hospital (World Health Organization performance scores 0 or 1).Results: A high number of serious adverse events in the nonsurgical arm led to premature closure of the trial. Ten patients were allocated to surgical treatment and 11 patients to nonsurgical palliation. The median survival in good health out of hospital during the first year was 56 days (interquartile range 7.5 - 338.5 days) in the surgical arm vs. 38 days (interquartile range 5.25 - 288.75 days) in the nonsurgical arm (P = 0.68). Eleven adverse events (six perforations) occurred in the nonsurgical arm vs. one adverse event in the surgical arm (P < 0.001). Of the six perforations, two were stent-related because they occurred at the proximal edge of the stent by erosion through a normal colon wall; one was probably stent-related (it was located in the region of the proximal half of the stent); one was a colon blowout; and two were late tumor perforations in patients on chemotherapy.Conclusions: The unexpected high rate of perforation in the nonsurgical arm might be specifically WallFlex-related or enteral stent-related in patients on chemotherapy and warrants attention.

References

  • 1 Parkin D M, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002.  CA Cancer J Clin. 2005;  55 74-108
    Search in Google Scholar
  • 2 CCCnet. Comprehensive Cancer Centers 2005 .Available from: http://www.ikcnet.nl/cijfers/index.php
  • 3 Harris G J, Senagore A J, Lavery I C, Fazio V W. The management of neoplastic colorectal obstruction with colonic endoluminal stenting devices.  Am J Surg. 2001;  181 499-506
    CrossrefPubMedSearch in Google Scholar
  • 4 Allen-Mersh T G, Earlam S, Fordy C. et al . Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases.  aLancet. 1994;  344 1255-1260
    CrossrefPubMedSearch in Google Scholar
  • 5 Cunningham D, Pyrhonen S, James R D. et al . Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.  Lancet. 1998;  352 1413-1418
    CrossrefPubMedSearch in Google Scholar
  • 6 Meyerhardt J A, Mayer R J. Systemic therapy for colorectal cancer.  N Engl J Med. 2005;  352 476-487
    CrossrefPubMedSearch in Google Scholar
  • 7 Scheithauer W, Rosen H, Kornek G V. et al . Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer.  BMJ. 1993;  306 752-755
    CrossrefPubMedSearch in Google Scholar
  • 8 Smyth J F, Hardcastle J D, Denton G. et al . Two phase III trials of tauromustine (TCNU) in advanced colorectal cancer.  Ann Oncol. 1995;  6 948-949
    PubMedSearch in Google Scholar
  • 9 Dohmoto M, Rupp K D, Hohlbach G. Endoscopically-implanted prosthesis in rectal carcinoma [in German, no abstract].  Dtsch Med Wochenschr. 1990;  115 915
    PubMedSearch in Google Scholar
  • 10 Tejero E, Mainar A, Fernandez L. et al . New procedure for the treatment of colorectal neoplastic obstructions.  Dis Colon Rectum. 1994;  37 1158-1159
    CrossrefPubMedSearch in Google Scholar
  • 11 Sebastian S, Johnston S, Geoghegan T. et al . Pooled analysis of the efficacy and safety of self-expanding metal stenting in malignant colorectal obstruction.  Am J Gastroenterol. 2004;  99 2051-2057
    CrossrefPubMedSearch in Google Scholar
  • 12 Khot U P, Lang A W, Murali K, Parker M C. Systematic review of the efficacy and safety of colorectal stents.  Br J Surg. 2002;  89 1096-1102
    CrossrefPubMedSearch in Google Scholar
  • 13 Johnson R, Marsh R, Corson J, Seymour K. A comparison of two methods of palliation of large bowel obstruction due to irremovable colon cancer.  Ann R Coll Surg Engl. 2004;  86 99-103
    CrossrefPubMedSearch in Google Scholar
  • 14 Law W L, Choi H K, Chu K W. Comparison of stenting with emergency surgery as palliative treatment for obstructing primary left-sided colorectal cancer.  Br J Surg. 2003;  90 1429-1433
    CrossrefPubMedSearch in Google Scholar
  • 15 Xinopoulos D, Dimitroulopoulos D, Theodosopoulos T. et al . Stenting or stoma creation for patients with inoperable malignant colonic obstructions? Results of a study and cost-effectiveness analysis.  Surg Endosc. 2004;  18 421-426
    CrossrefPubMedSearch in Google Scholar
  • 16 Fiori E, Lamazza A, de CA . et al . Palliative management of malignant rectosigmoidal obstruction. Colostomy vs. endoscopic stenting: a randomized prospective trial.  Anticancer Res. 2004;  24 265-268
    PubMedSearch in Google Scholar
  • 17 Carne P W, Frye J N, Robertson G M, Frizelle F A. Stents or open operation for palliation of colorectal cancer: a retrospective, cohort study of perioperative outcome and long-term survival.  Dis Colon Rectum. 2004;  47 1455-1461
    CrossrefPubMedSearch in Google Scholar
  • 18 Hurwitz H, Fehrenbacher L, Novotny W. et al . Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer.  N Engl J Med. 2004;  350 2335-2342
    CrossrefPubMedSearch in Google Scholar
  • 19 Kabbinavar F F, Schulz J, McCleod M. et al . Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial.  J Clin Oncol. 2005;  23 3697-3705
    CrossrefPubMedSearch in Google Scholar
  • 20 Karoui M, Charachon A, Delbaldo C. et al . Stents for palliation of obstructive metastatic colon cancer: impact on management and chemotherapy administration.  Arch Surg. 2007;  142 619-623
    CrossrefPubMedSearch in Google Scholar
  • 21 Aaronson N K, Ahmedzai S, Bergman B. et al . The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.  J Natl Cancer Inst. 1993;  85 365-376
    CrossrefPubMedSearch in Google Scholar
  • 22 Lamers L M, McDonnell J, Stalmeier P F. et al . The Dutch tariff: results and arguments for an effective design for national EQ-5D valuation studies.  Health Econ. 2006;  15 1121-1132
    CrossrefPubMedSearch in Google Scholar
  • 23 van Hooft J E, Fockens P, Marinelli A W. et al . Premature closure of the Dutch Stent-in I study.  Lancet. 2006;  368 1573-1574
    PubMedSearch in Google Scholar
  • 24 Athreya S, Moss J, Urquhart G. et al . Colorectal stenting for colonic obstruction: the indications, complications, effectiveness and outcome: 5-year review.  Eur J Radiol. 2006;  60 91-94
    CrossrefPubMedSearch in Google Scholar
  • 25 Suzuki N, Saunders B P, Thomas-Gibson S. et al . Colorectal stenting for malignant and benign disease: outcomes in colorectal stenting.  Dis Colon Rectum. 2004;  47 1201-1207
    CrossrefPubMedSearch in Google Scholar
  • 26 Duda S H, Wiskirchen J, Tepe G. et al . Physical properties of endovascular stents: an experimental comparison.  J Vasc Interv Radiol. 2000;  11 645-654
    CrossrefPubMedSearch in Google Scholar
  • 27 Dyet J F, Watts W G, Ettles D F, Nicholson A A. Mechanical properties of metallic stents: how do these properties influence the choice of stent for specific lesions?.  Cardiovasc Intervent Radiol. 2000;  23 47-54
    CrossrefPubMedSearch in Google Scholar
  • 28 Stoeckel D, Pelton A, Duerig T. Self-expanding nitinol stents: material and design considerations.  Eur Radiol. 2004;  14 292-301
    CrossrefPubMedSearch in Google Scholar
  • 29 Palliative chemotherapy for advanced or metastatic colorectal cancer. Colorectal Meta-analysis Collaboration.  Cochrane Database Syst Rev. 2000;  CD001545
    PubMedSearch in Google Scholar
  • 30 Costi R, Mazzeo A, di MD . et al . Palliative resection of colorectal cancer: does it prolong survival?.  Ann Surg Oncol. 2007;  14 2567-2576
    CrossrefPubMedSearch in Google Scholar
  • 31 Konyalian V R, Rosing D K, Haukoos J S. et al . The role of primary tumour resection in patients with stage IV colorectal cancer.  Colorectal Dis. 2007;  9 430-437
    CrossrefPubMedSearch in Google Scholar
  • 32 Kuo L J, Leu S Y, Liu M C. et al . How aggressive should we be in patients with stage IV colorectal cancer?.  Dis Colon Rectum. 2003;  46 1646-1652
    CrossrefPubMedSearch in Google Scholar
  • 33 Liu S K, Church J M, Lavery I C, Fazio V W. Operation in patients with incurable colon cancer: is it worthwhile?.  Dis Colon Rectum. 1997;  40 11-14
    CrossrefPubMedSearch in Google Scholar
  • 34 Ruo L, Gougoutas C, Paty P B. et al . Elective bowel resection for incurable stage IV colorectal cancer: prognostic variables for asymptomatic patients.  J Am Coll Surg. 2003;  196 722-728
    CrossrefPubMedSearch in Google Scholar
  • 35 Tekkis P P, Poloniecki J D, Thompson M R, Stamatakis J D. Operative mortality in colorectal cancer: prospective national study.  BMJ. 2003;  327 1196-1201
    CrossrefPubMedSearch in Google Scholar
  • 36 Targownik L E, Spiegel B M, Sack J. et al . Colonic stent vs. emergency surgery for management of acute left-sided malignant colonic obstruction: a decision analysis.  Gastrointest Endosc. 2004;  60 865-874
    CrossrefPubMedSearch in Google Scholar

1 See Appendix

W. A. Bemelman, MD, PhD 

Academic Medical Center
Department of Surgery

Meibergdreef 9
1105 AZ Amsterdam
The Netherlands

Fax: +31-206914858

Email: W.A.Bemelman@amc.nl