Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial

Heiko Pohl, Ian S. Grimm, Matthew T. Moyer, Muhammad K. Hasan, Douglas Pleskow, B. Joseph Elmunzer, Mouen A. Khashab, Omid Sanaei, Firas H. Al-Kawas, Stuart R. Gordon, Abraham Mathew, John M. Levenick, Harry R. Aslanian, Fadi Antaki, Daniel von Renteln, Seth D. Crockett, Amit Rastogi, Jeffrey A. Gill, Ryan J. Law, Pooja A. EliasMaria Pellise, Michael B. Wallace, Todd A. Mackenzie, Douglas Rex

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background & Aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%–6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%–10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD –2.6%; 95% CI –6.3% to –1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%–8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

Original languageEnglish (US)
Pages (from-to)977-984.e3
JournalGastroenterology
Volume157
Issue number4
DOIs
StatePublished - Oct 1 2019

Fingerprint

Polyps
Surgical Instruments
Colon
Hemorrhage
Control Groups
Confidence Intervals
Colonoscopy
North America
Blood Transfusion
Spain
Multicenter Studies
Hospitalization
Morbidity
Costs and Cost Analysis

Keywords

  • Colonoscopy
  • Complications
  • Endoscopic Mucosal Resection
  • Polyp Resection

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Pohl, H., Grimm, I. S., Moyer, M. T., Hasan, M. K., Pleskow, D., Elmunzer, B. J., ... Rex, D. (2019). Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology, 157(4), 977-984.e3. https://doi.org/10.1053/j.gastro.2019.03.019

Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. / Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Wallace, Michael B.; Mackenzie, Todd A.; Rex, Douglas.

In: Gastroenterology, Vol. 157, No. 4, 01.10.2019, p. 977-984.e3.

Research output: Contribution to journalArticle

Pohl, H, Grimm, IS, Moyer, MT, Hasan, MK, Pleskow, D, Elmunzer, BJ, Khashab, MA, Sanaei, O, Al-Kawas, FH, Gordon, SR, Mathew, A, Levenick, JM, Aslanian, HR, Antaki, F, von Renteln, D, Crockett, SD, Rastogi, A, Gill, JA, Law, RJ, Elias, PA, Pellise, M, Wallace, MB, Mackenzie, TA & Rex, D 2019, 'Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial', Gastroenterology, vol. 157, no. 4, pp. 977-984.e3. https://doi.org/10.1053/j.gastro.2019.03.019
Pohl, Heiko ; Grimm, Ian S. ; Moyer, Matthew T. ; Hasan, Muhammad K. ; Pleskow, Douglas ; Elmunzer, B. Joseph ; Khashab, Mouen A. ; Sanaei, Omid ; Al-Kawas, Firas H. ; Gordon, Stuart R. ; Mathew, Abraham ; Levenick, John M. ; Aslanian, Harry R. ; Antaki, Fadi ; von Renteln, Daniel ; Crockett, Seth D. ; Rastogi, Amit ; Gill, Jeffrey A. ; Law, Ryan J. ; Elias, Pooja A. ; Pellise, Maria ; Wallace, Michael B. ; Mackenzie, Todd A. ; Rex, Douglas. / Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. In: Gastroenterology. 2019 ; Vol. 157, No. 4. pp. 977-984.e3.
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abstract = "Background & Aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5{\%} of patients in the clip group and 7.1{\%} in the control group (absolute risk difference [ARD] 3.6{\%}; 95{\%} confidence interval [CI] 0.7{\%}–6.5{\%}). Among 615 patients (66.9{\%}) with a proximal large polyp, the risk of bleeding in the clip group was 3.3{\%} and in the control group was 9.6{\%} (ARD 6.3{\%}; 95{\%} CI 2.5{\%}–10.1{\%}); among patients with a distal large polyp, the risks were 4.0{\%} in the clip group and 1.4{\%} in the control group (ARD –2.6{\%}; 95{\%} CI –6.3{\%} to –1.1{\%}). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8{\%} of patients in the clip group and 9.5{\%} of patients in the control group (ARD 4.6{\%}; 95{\%} CI 1.3{\%}–8.0{\%}). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.",
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TY - JOUR

T1 - Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial

AU - Pohl, Heiko

AU - Grimm, Ian S.

AU - Moyer, Matthew T.

AU - Hasan, Muhammad K.

AU - Pleskow, Douglas

AU - Elmunzer, B. Joseph

AU - Khashab, Mouen A.

AU - Sanaei, Omid

AU - Al-Kawas, Firas H.

AU - Gordon, Stuart R.

AU - Mathew, Abraham

AU - Levenick, John M.

AU - Aslanian, Harry R.

AU - Antaki, Fadi

AU - von Renteln, Daniel

AU - Crockett, Seth D.

AU - Rastogi, Amit

AU - Gill, Jeffrey A.

AU - Law, Ryan J.

AU - Elias, Pooja A.

AU - Pellise, Maria

AU - Wallace, Michael B.

AU - Mackenzie, Todd A.

AU - Rex, Douglas

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Background & Aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%–6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%–10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD –2.6%; 95% CI –6.3% to –1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%–8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

AB - Background & Aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%–6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%–10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD –2.6%; 95% CI –6.3% to –1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%–8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

KW - Colonoscopy

KW - Complications

KW - Endoscopic Mucosal Resection

KW - Polyp Resection

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