Evidence map›Paper›PMID 33461579›Full record

ArticleTrials2021

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial.

Ayla S Turan, Leon M G Moons, Ramon-Michel Schreuder, Erik J Schoon, Jochim S Terhaar Sive Droste, Ruud W M Schrauwen, Jan Willem Straathof, Barbara A J Bastiaansen, Matthijs P Schwartz, Wouter L Hazen and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03309683 (Clip Placement Following Colonic Endoscopic Mucosal Resection), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
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.

NCT03309683 nacompletednot on this map

Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail

TypeinterventionalSponsorRadboud University Medical CenterRan2018 to 2023Enrolled356ConditionsPolyp, Colonic, BleedingArmsOlympus Quick Clip Pro - Single Use Repositionable Clips
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 11 institutions in 1 country.

Ayla S TuranDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands. ayla.turan@radboudumc.nl.ORCID http://orcid.org/0000-0002-1301-1089
Leon M G MoonsDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands.
Ramon-Michel SchreuderDepartment of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands.
Erik J SchoonDepartment of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands.
Jochim S Terhaar Sive DrosteDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, s' Hertogenbosch, Netherlands.
Ruud W M SchrauwenDepartment of Gastroenterology and Hepatology, Bernhoven, Uden, Netherlands.
Jan Willem StraathofDepartment of Gastroenterology and Hepatology, Màxima Medical Center, Veldhoven, Netherlands.
Barbara A J BastiaansenDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers, location Academic Medical Center, Amsterdam, Netherlands.
Matthijs P SchwartzDepartment of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands.
Wouter L HazenDepartment of Gastroenterology and Hepatology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.
Alaa AlkhalafDepartment of Gastroenterology and Hepatology, Isala Clinics, Zwolle, Netherlands.
Daud AllajarDepartment of Gastroenterology and Hepatology, Hospital St. Jansdal, Harderwijk, Netherlands.
Muhammed HadithiDepartment of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands.
Bas W van der SpekDepartment of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands.
Dimitri G D N HeineDepartment of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, Netherlands.
Adriaan C I T L TanDepartment of Gastroenterology and Hepatology, Canisius-Wilhelmina hospital, Nijmegen, Netherlands.
Wilmar de GraafDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands.
Jurjen J BoonstraDepartment of Gastroenterology and Hepatology, Leids University Medical Center, Leiden, Netherlands.
Fia J VoogdDepartment of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, Netherlands.
Robert RoomerDepartment of Gastroenterology and Hepatology, Franciscus Gasthuis, Rotterdam, Netherlands.
Rogier J J de RidderDepartment of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, Netherlands.
Wietske KievitIQ Healthcare, Radboud University Medical Center, Nijmegen, Netherlands.
Peter D SiersemaDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands.
Paul DiddenDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands.
Erwin J M van GeenenDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands.
Dutch EMR Study Group
Radboud University Nijmegen · NLNoordwest Ziekenhuisgroep · NLIsala · NLLeiden University Medical Center · NLAmsterdam UMC Location University of Amsterdam · NLElisabeth-TweeSteden Ziekenhuis · NLErasmus MC · NLMaasstad Ziekenhuis · NLMaastricht University · NLMedisch Centrum Leeuwarden · NLZiekenhuis Bernhoven · NL

Funding

Maag Lever Darm Stichting F16-08
6 · The paper itself

Abstract

backgroundEndoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk.

methodsThe CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. DISCUSSION: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice.

trial registrationClinicalTrials.gov NCT03309683 . Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021.

Indexed as

Colonic PolypsEndoscopic Mucosal ResectionColonColonoscopyEquivalence Trials as TopicHumansMulticenter Studies as TopicNetherlandsPostoperative HemorrhagePragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSurgical InstrumentsClip artifactColonic polypDelayed bleedingEMRProphylactic clipping

Identifiers

PMID33461579
PMCPMC7813164
OpenAlexW3124461344

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.