Evidence map›Paper›PMID 38368409›Full record

ArticleTrials2024

Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial.

Gijs Kemper, Christian Gerges, Erik J Schoon, Ramon-Michel Schreuder, Ruud R W Schrauwen, Ludger S M Epping, Torsten Beyna, Joost P H Drenth, Ufuk Gündug, Peter D Siersema and 2 more

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

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05121805 (Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT05121805 naunknown statusnot on this map

Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma

TypeinterventionalSponsorRadboud University Medical CenterRan2022 to 2024Enrolled306ConditionsPolyps of Colon, Recurrence, Local NeoplasmArmsSnare tip soft coagulation
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

12 authors at 5 institutions in 2 countries.

Gijs KemperDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands. gijs.kemper@radboudumc.nl.ORCID http://orcid.org/0000-0002-1693-2676
Christian GergesDepartment of General Internal Medicine and Gastroenterology, Evangelical Hospital Düsseldorf, Düsseldorf, Germany.
Erik J SchoonDepartment of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Ramon-Michel SchreuderDepartment of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Ruud R W SchrauwenDepartment of Gastroenterology and Hepatology, Bernhoven, Uden, The Netherlands.
Ludger S M EppingDepartment of Gastroenterology and Hepatology, Maasziekenhuis Pantein, Boxmeer, The Netherlands.
Torsten BeynaDepartment of General Internal Medicine and Gastroenterology, Evangelical Hospital Düsseldorf, Düsseldorf, Germany.
Joost P H DrenthDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.
Ufuk GündugDepartment of Internal Medicine and Gastroenterology, Katholisches Karl Leisner Klinikum - St.-Antonius-Hospital Kleve, Kleve, Germany.
Peter D SiersemaDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.
Erwin J M van GeenenDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.
ENDOCARE study group
Radboud University Nijmegen · NLEvangelisches Krankenhaus Düsseldorf · DEKatholisches Klinikum Bochum · DEMaaslandziekenhuis · NLZiekenhuis Bernhoven · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of up to 20%. Snare tip soft coagulation (STSC) is considered an effective technique to reduce recurrence rates. However, clinical trials on STSC have mainly been conducted in expert referral centers. In these studies, polyp recurrence was assessed optically, and additional adjunctive techniques were excluded. In the current trial, we will evaluate the efficacy and safety of STSC in daily practice, by allowing adjunctive techniques during EMR and the use of both optical and histological polyp recurrence to assess recurrences during follow-up.

methodsThe RESPECT study is a multicenter, parallel-group, international single blinded randomized controlled superiority trial performed in the Netherlands and Germany. A total of 306 patients undergoing piecemeal EMR for LSLs or sessile colorectal polyps sized 20-60 mm will be randomized during the procedure after endoscopic complete polyp resection to the intervention or control group. Post-EMR defects allocated to the intervention group will be treated with thermal ablation with STSC of the entire resection margin. Primary outcome will be polyp recurrence by optical and histological confirmation at the first surveillance colonoscopy after 6 months. Secondary outcomes include technical success and complication rates. DISCUSSION: The RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification.

trial registrationClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.

Indexed as

AdenomaColonic PolypsColorectal NeoplasmsEndoscopic Mucosal ResectionColonoscopyEquivalence Trials as TopicHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalRandomized Controlled Trials as TopicTreatment OutcomeColonic polypsEndoscopic mucosal resectionLocal neoplasm recurrenceRandomized controlled trialThermal ablation

Identifiers

PMID38368409
PMCPMC10874049
OpenAlexW4391897059

What OpenQuestion holds

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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.