Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps

NCT05029934 | Terminated

• 1 other identifier: PV7200
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

Brief Summary

The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Effective and safe resection of larger polyps is particularly important due to their higher potential of malignancy. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) (and occasionally endoscopic submucosal dissection (ESD)) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-10% of patients. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways. Our primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.

Conditions

Wound Endoscopical, Colon; After Polyp Resection, Colon

Keywords

colon endoscopic mucosa resection (EMR); delayed bleeding; colonoscopy; polyp resection

Outcome Measures

Primary Outcomes (4)

• delayed bleeding complication: hospitalization

  hospitalization after subsequent return to unit / health care facility for evaluation of rectal bleeding

  30 days

• delayed bleeding complication: transfusion

  a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required transfusion

  30 days

• delayed bleeding complication: repeat endoscopy

  a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required a repeat colonoscopy or sigmoidoscopy for examination of the polypectomy site or control of bleeding

  30 days

• delayed bleeding complication:

  a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required surgery

  30 days

Secondary Outcomes (7)

• Technical handling

  20 minutes (assumed deployment time)

• Overall complications

  procedure to day 30

• Factors associated with complications: polyp size

  30 days

• Factors associated with complications: polyp location

  30 days

• Factors associated with complications: polyp histology

  30 days

Study Arms (2)

EndoClot group

ACTIVE COMPARATOR

patients who are being provided with EndoClot adhesive spray after polyp resection

Procedure: use of EndoClot

Control group

SHAM COMPARATOR

no further prophylactic bleeding prevention after polyp resection

Procedure: use of EndoClot

Interventions

use of EndoClot PROCEDURE

deployment of EndoClot adhesive spray

Control group; EndoClot group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a ≥20mm colon non-pedunculated polyp who are undergoing an ESD or EMR resection
• signed Informed Consent

You may not qualify if:

• Patients with known (biopsy proven) or strongly suspected invasive carcinoma in a potential study polyp
• Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
• ulcerated depressed lesions (as defined by Paris Classification type III)
• polyposis syndromes
• inflammatory bowel disease
• emergency colonoscopy
• Poor general health (ASA (American Society of Anaesthesiologists) class\>3)
• Patients with coagulopathy with an elevated International Normalized Ratio (INR )≥1.5, or platelets \<50
• Poor bowel preparation
• pregnancy or breastfeeding
• Intervention planned using ORISE™ (Boston Medical) or LIFTUP™ (Ovesco) as lifting agents

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (5)

Vivantes Auguste-Viktoria-Klinikum

Berlin, 12099, Germany

Location

University Hospital Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Evangelisches Amalie Sieveking Krankenhaus

Hamburg, 22359, Germany

Location

UKGM Marburg, Klinik für Gastroenterologie

Marburg, 35043, Germany

Location

Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed about the use of EndoClot adhesive
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: use of EndoClot adhesive after resection vs no use of any preventive action against delayed bleeding (control group)

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 1, 2021
• Study Start: August 18, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

DE (5)