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.

Colonic polyps Endoscopic mucosal resection Local neoplasm recurrence Randomized controlled trial Thermal ablation

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
17 Feb 2024
Historique:
received: 22 06 2023
accepted: 09 01 2024
medline: 18 2 2024
pubmed: 18 2 2024
entrez: 17 2 2024
Statut: epublish

Résumé

Nowadays, 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. The 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. 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. ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.

Sections du résumé

BACKGROUND BACKGROUND
Nowadays, 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.
METHODS METHODS
The 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 CONCLUSIONS
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 REGISTRATION BACKGROUND
ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.

Identifiants

DOI: 10.1186/s13063-024-07915-2 PMID: 38368409
pubmed: 38368409
doi: 10.1186/s13063-024-07915-2
pii: 10.1186/s13063-024-07915-2
doi:

Banques de données

ClinicalTrials.gov
['NCT05121805']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

132

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Gijs Kemper (G)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands. gijs.kemper@radboudumc.nl.
ORCID: 0000-0002-1693-2676

Christian Gerges (C)

Department of General Internal Medicine and Gastroenterology, Evangelical Hospital Düsseldorf, Düsseldorf, Germany.

Erik J Schoon (EJ)

Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.

Ramon-Michel Schreuder (RM)

Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.

Ruud R W Schrauwen (RRW)

Department of Gastroenterology and Hepatology, Bernhoven, Uden, The Netherlands.

Ludger S M Epping (LSM)

Department of Gastroenterology and Hepatology, Maasziekenhuis Pantein, Boxmeer, The Netherlands.

Torsten Beyna (T)

Department of General Internal Medicine and Gastroenterology, Evangelical Hospital Düsseldorf, Düsseldorf, Germany.

Joost P H Drenth (JPH)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.

Ufuk Gündug (U)

Department of Internal Medicine and Gastroenterology, Katholisches Karl Leisner Klinikum - St.-Antonius-Hospital Kleve, Kleve, Germany.

Peter D Siersema (PD)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.
Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands.

Erwin J M van Geenen (EJM)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.

Classifications MeSH