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Completed

NCT Number: NCT01936948

Safety of 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. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) 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 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

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Key information

Conditions

Colon Polyps Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

White River Junction VAMC

White River Junction, Vermont, 05009, United States

About this study

Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:

  • A) Closing the mucosal defect after resection (Clip group) and
  • B) Not closing the mucosal defect after resection (No clip group).

Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:

  • A) Low power coagulation and
  • B) Endocut.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
  • Patients with a ≥20mm non-pedunculated colon polyp

Exclusion criteria

  • Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
  • Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
  • Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
  • Patients with inflammatory bowel disease
  • Patients who are receiving an emergency colonoscopy
  • Poor general health (ASA class>3)
  • Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
  • Poor bowel preparation
  • Pregnancy

Treatment and study plan

Clip Closure

Procedure

Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Primary outcomes

  1. Number of Participants With Delayed Bleeding Complications

    Time frame: 30 days following a study polyp resection

    A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.

Secondary outcomes

  1. The Overall Number of Complications

    Time frame: 30 days

    Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.

  2. Complete Study Polyp Resection Rate

    Time frame: 6 months

    Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy

  3. Polyp Recurrence Rate

    Time frame: 3 months to 5 years

    Rate of recurrent polyp at the resection site after complete polyp resection.

  4. The Number of Complications Associated With Clip Use

    Time frame: 30 days

    Incidence of complications associated with application of clips.

Other outcomes

  1. Measured Factors Associated With Resection Complications

    Time frame: 30 days

    Factors that may be associated with complications, including electrocautery setting, polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection.

  2. Measured Factors Associated With Incomplete Resection or Recurrence of Polyps

    Time frame: 5 years

    Factors that may be associated with incomplete resection may include prior attempts of removal, use of adjunctive argon plasma coagulation for residual polyp removal, polyp size, location, histology.

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • Boston Scientific Corporation
  • Dartmouth College

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2022
First posted
Sep 6, 2013
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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