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

July 1, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf

Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer is the second most common cause of cancer death in the United States and Europe. The effectiveness of colonoscopy in reducing the risk of dying from colorectal cancer relies on the detection and safe resection of neoplastic polyps to prevent incident cancers. Most polyps are small and can be easily removed using snare with or without electrocautery. Because the risk of prevalent cancer or transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important.

Endoscopic mucosal resection (EMR) is evolving as the primary endoscopic technique to remove large non-pedunculated polyps. These flat or sessile polyps are defined as lateral spreading tumors with a low vertical axis that extend laterally along the luminal wall. Several mostly retrospective studies from Europe, the U.S. and Japan, have demonstrated a high "cure" rate, with results lending credence to the shift from surgical resection to endoscopic management of these lesions. Of concern, however, is 1) a fairly high overall complication rate of 8-26% in prospective studies3-7, and 2) as well the persistence of residual neoplasia on follow-up endoscopy ranging from 16% to 46%3, 6, 8. The former is the main topic of the present study.

Severe complications including bleeding associated with a standard diagnostic or screening colonoscopy, which may include resection of predominantly smaller polyps, are uncommon. Significant bleeding occurs in 0.2 to 0.5% of patients (defined as a 2mg drop in Hemoglobin) 9, 10. The risk of severe complications increases with polyp size; here, again, the most common complication is bleeding reported in 2 to 24% of polyp resections. In one recent analysis the rate of delayed bleeding in colonic EMR was 7.5%1.

In addition to size, other factors may affect complications. These include type of resection (piecemeal versus en-bloc), polyp location (right colon with a thinner wall than the left colon), age and comorbidities, especially those that affect clotting abilities (e.g. renal insufficiency, liver disease, use of anticoagulation). Studies that have examined variables, which may directly decrease the risk of complications associated with large polyp resection, are limited.

It is apparent that resection of a large polyp leaves behind a large mucosal defect. The mucosal ulcer that forms after polyp resection can take several weeks to heal. Bleeding complications typically occur within 7 to 10 days, requiring often admission, a repeat colonoscopy to stop bleeding, and possible blood transfusions. The rates depend on size, and have been shown to be around 1.5%-2.6% overall. It is significantly higher in larger adenomas of 2 cm and more, namely 6.5% in another recent meta analysis.

To reduce the risk of bleeding various measures have been proposed which also have been summarized in several recent meta analyses. These include coagulation, clipping and others, but only few randomized trials are available: Coagulation not effective in a recent meta analysis14, but only 4 of the 12 studies were randomized and these included all mostly smaller polyps or polyps of all sizes or pedunculated polyps. 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12099
        • Vivantes Auguste-Viktoria-Klinikum
      • Hamburg, Germany, 20246
        • University Hospital Hamburg Eppendorf
      • Hamburg, Germany, 22359
        • Evangelisches Amalie Sieveking Krankenhaus
      • Marburg, Germany, 35043
        • UKGM Marburg, Klinik für Gastroenterologie
      • Rostock, Germany, 18059
        • Klinikum Südstadt Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EndoClot group
patients who are being provided with EndoClot adhesive spray after polyp resection
Procedure: use of EndoClot
deployment of EndoClot adhesive spray
Sham Comparator: Control group
no further prophylactic bleeding prevention after polyp resection
Procedure: use of EndoClot
deployment of EndoClot adhesive spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed bleeding complication: hospitalization
Time Frame: 30 days
hospitalization after subsequent return to unit / health care facility for evaluation of rectal bleeding
30 days
delayed bleeding complication: transfusion
Time Frame: 30 days
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
Time Frame: 30 days
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:
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical handling
Time Frame: 20 minutes (assumed deployment time)
product deployment assumed quantity of entire vial: < 50%/50-70%/100%
20 minutes (assumed deployment time)
Overall complications
Time Frame: procedure to day 30
an aggregate of all complications that occur at the time of the procedure or during follow-up
procedure to day 30
Factors associated with complications: polyp size
Time Frame: 30 days
Factors that may be associated with complications, esp. bleeding
30 days
Factors associated with complications: polyp location
Time Frame: 30 days
Factors that may be associated with complications, esp. bleeding: location of the polyp in the colon (right, left, rectum)
30 days
Factors associated with complications: polyp histology
Time Frame: 30 days
Factors that may be associated with complications, esp. bleeding
30 days
Factors associated with complications: polyp morphology
Time Frame: 30 days
Factors that may be associated with complications, esp. bleeding
30 days
Factors associated with complications: polyp resection time
Time Frame: 30 days
Factors that may be associated with complications, esp. bleeding
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 27, 2023

Study Registration Dates

First Submitted

August 29, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV7200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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