Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR)

NCT03309683 | Completed

• 1 other identifier: R0003871
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 2

Brief Summary

Study design: A national, multi-center, patient-blinded, randomized clinical trial. Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon, ≥2cm) of developing Delayed Bleeding (DB). Intervention: PC will be compared to standard care (no PC). Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma recurrence and risk factors for DB.

Conditions

Polyp, Colonic; Bleeding

Outcome Measures

Primary Outcomes (1)

• Delayed bleeding

  Clinical relevant delayed bleeding defined according to the ASGE working party document for adverse events in coloscopy.

  30 days

Secondary Outcomes (3)

• Adenoma recurrence

  180 days

• Cost-effectiveness

  180 days

• EMR scar evaluation

  180 days

Study Arms (2)

Clip group

EXPERIMENTAL

Olympus Quick Clip Pro - Single Use Repositionable Clips will be used for Prophylactic clipping after EMR

Device: Olympus Quick Clip Pro - Single Use Repositionable Clips

Control group

NO INTERVENTION

Standard treatment after EMR (as described in the detailed study description above)

Interventions

Olympus Quick Clip Pro - Single Use Repositionable Clips DEVICE

A hemoclip will be placed after every 0,5-1,0 cm of the resected area to proximate wound edges.

Also known as: prophylactic clipping, hemoclip

Clip group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• laterally spreading or sessile polyp morphology (Paris classification 0-IIa/b/c) proximal to the splenic flexure, measuring 2-6 cm
• All patients aged \>18 years undergoing an EMR
• Written informed consent

You may not qualify if:

• Previous resection or attempted resection of a lesion less than 30 days ago or in the same session,
• Clip deployed prior to the completion of the EMR for a perforation or a major intra-procedural bleeding not treatable by coagulation,
• Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit pattern),
• Pregnancy,
• Active inflammatory colonic conditions (e.g. inflammatory bowel disease),
• Insufficiently corrected anticoagulants AND/OR a clotting disorder (platelet count \<50x109/l, INR \> 1,5),
• American Society of Anesthesiology (ASA) Grade IV-V,
• Macroscopic non-radical resection,
• \>1 lesion in 1 session,
• Involvement of valvula Bauhin or appendiceal orificium

Sponsors & Collaborators

• Radboud University Medical Center: lead
• UMC Utrecht: collaborator
• Maastricht University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Maxima Medical Center: collaborator
• Jeroen Bosch Ziekenhuis: collaborator
• Bernhoven Hospital: collaborator
• Isala: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• Maasstad Hospital: collaborator
• Noordwest Ziekenhuisgroep: collaborator
• Meander Medisch Centrum: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• St Jansdal Hospital: collaborator
• Leiden University Medical Center: collaborator
• Dutch Digestive Diseases Foundation: collaborator
• Franciscus Gasthuis: collaborator
• Bravis Hospital: collaborator

Study Sites (2)

Ziekenhuis St Jansdal

Harderwijk, Gelderland, 3844DG, Netherlands

Location

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (2)

• Kemper G, Turan AS, Schreuder RM, Schrauwen RWM, Hadithi M, Didden P, Bastiaansen BAJ, van der Spek BW, Droste JSTS, Schwartz MP, Hazen WL, Straathof JWA, Boonstra JJ, Alkhalaf A, Voogd FJ, Allajar D, de Graaf W, Koehestanie P, Roomer R, de Ridder RJJ, Moons LMG, Siersema PD, van Geenen EJM; Dutch EMR Study Group. The effect of prophylactic clipping on delayed bleeding after proximal colonic endoscopic mucosal resection: a multicenter, randomized controlled trial (CLIPPER). Endoscopy. 2025 Nov;57(11):1243-1250. doi: 10.1055/a-2637-3180. Epub 2025 Jul 22.

  PMID: 40695477 DERIVED

• Turan AS, Moons LMG, Schreuder RM, Schoon EJ, Terhaar Sive Droste JS, Schrauwen RWM, Straathof JW, Bastiaansen BAJ, Schwartz MP, Hazen WL, Alkhalaf A, Allajar D, Hadithi M, van der Spek BW, Heine DGDN, Tan ACITL, de Graaf W, Boonstra JJ, Voogd FJ, Roomer R, de Ridder RJJ, Kievit W, Siersema PD, Didden P, van Geenen EJM; Dutch EMR Study Group. Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial. Trials. 2021 Jan 18;22(1):63. doi: 10.1186/s13063-020-04996-7.

  PMID: 33461579 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Hemorrhage

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Erwin JM Van Geenen, dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 13, 2017
• Study Start: March 5, 2018
• Primary Completion: August 19, 2022
• Study Completion: March 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)