Evidence map›Paper›PMID 30885778›Full record

Trial reportGastroenterology2019

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 and 14 more

5 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 100 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01936948 nacompletednot on this map

Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

TypeinterventionalSponsorWhite River Junction Veterans Affairs Medical CenterRan2013 to 2022Enrolled928ConditionsColon PolypsArmsClip closure
NCT04559880 phase4completednot on this mapstarted 2020, after this paper: background citation

Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project

TypeinterventionalSponsorLawrence Charles HookeyRan2020 to 2023Enrolled25ConditionsPolyp, ColorectalArmsTranexamic Acid Injection [Cyklokapron]
NCT04925271 nacompletednot on this mapstarted 2021, after this paper: background citation

Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

TypeinterventionalSponsorThomas Jefferson UniversityRan2021 to 2022Enrolled40ConditionsPolyp of Colon, FistulaArmsX-Tack, Overstitch
NCT05029934 naterminatednot on this mapstarted 2021, after this paper: background citation

Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2021 to 2023Enrolled96ConditionsWound Endoscopical, Colon, After Polyp Resection, ColonArmsuse of EndoClot
NCT06443047 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects

TypeinterventionalSponsorIstituto Clinico HumanitasRan2025 to 2026Enrolled66ConditionsPrecancerous Lesion of ColonArmsTTS suturing system
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Heiko PohlDartmouth Geisel School of Medicine, Hanover, New Hampshire; Section of Gastroenterology and Hepatology, VA White River Junction, White River Junction, Vermont. Electronic address: Heiko.pohl@dartmouth.edu.
Ian S GrimmDivision of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Matthew T MoyerDivision of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania.
Muhammad K HasanCenter for Interventional Endoscopy, Florida Hospital, Orlando, Florida.
Douglas PleskowDivision of Gastroenterology Beth Israel Deaconess Medical Center, Boston, Massachusetts.
B Joseph ElmunzerDivision of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.
Mouen A KhashabDivision of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.
Omid SanaeiDivision of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland.
Firas H Al-KawasDivision of Gastroenterology and Hepatology, Johns Hopkins University, Sibley Memorial Hospital, Washington, DC.
Stuart R GordonDartmouth Geisel School of Medicine, Hanover, New Hampshire; Department of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.
Abraham MathewDivision of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
John M LevenickDivision of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Harry R AslanianSection of Digestive Diseases, Yale-New Haven Hospital, New Haven, Connecticut.
Fadi AntakiDivision of Gastroenterology, John D. Dingell Veterans Affairs Medical Center and Wayne State University, Detroit, Michigan.
Daniel von RentelnDivision of Gastroenterology, University of Montreal Medical Center (CHUM) and Research Center (CRCHUM), Montreal, QC, Canada.
Seth D CrockettDivision of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Amit RastogiDivision of Gastroenterology, Hepatology and Motility, University of Kansas Medical Center, Kansas City, Kansas.
Jeffrey A GillDivision of Gastroenterology James A. Haley VA, University of South Florida, Tampa, Florida.
Ryan J LawDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan.
Pooja A EliasDivision of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina.
Maria PelliseGastroenterology Department, Hospital Clínic de Barcelona, Barcelona, Spain.
Michael B WallaceDivision of Gastroenterology and Hepatology, Mayo Clinic Jacksonville, Jacksonville, Florida.
Todd A MackenzieThe Dartmouth Institute, Department for Biomedical Data Science, Lebanon, New Hampshire.
Douglas K RexIndiana University School of Medicine, Indianapolis, Indiana.

Funding

North Carolina Translational & Clinical Sciences Institute (NC TraCS)KL2TR001109 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$5.7M
NCATS NIH HHS KL2 TR001109
6 · The paper itself

Abstract

BACKGROUND &

aimsBleeding 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.

methodsWe 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.

resultsA 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%).

conclusionsIn 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.

Indexed as

Surgical InstrumentsAgedColectomyColonic PolypsColonoscopyEquipment DesignFemaleHemostatic TechniquesHumansMaleMiddle AgedNorth AmericaPostoperative HemorrhageRisk FactorsSpainTime FactorsColonoscopyComplicationsEndoscopic Mucosal ResectionPolyp Resection

Identifiers

PMID30885778
PMCPMC8224988

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.