Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial.
Trials
; 22(1): 63, 2021 Jan 18.
Article
en En
| MEDLINE
| ID: mdl-33461579
ABSTRACT
BACKGROUND:
Endoscopic 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.METHODS:
The 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 REGISTRATION ClinicalTrials.gov NCT03309683 . Registered on 13 October 2017. Start recruitment 05 March 2018. Planned completion of recruitment 31 August 2021.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pólipos del Colon
/
Resección Endoscópica de la Mucosa
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Países Bajos