Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by White River Junction VAMC
Sponsor:
Collaborator:
Center for Bioinformatics at Geisel School of Medicine at Dartmouth
Information provided by (Responsible Party):
Dr. Heiko Pohl, White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT01936948
First received: September 3, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Colon Polyps
Device: Resolution II clip

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

Resource links provided by NLM:


Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • Delayed bleeding complications [ Time Frame: 30 days following a study polyp resection ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Overall complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Complete polyp resection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy

  • Polyp recurrence [ Time Frame: 3 months to 5 years ] [ Designated as safety issue: No ]
    Rate of recurrent polyp at the resection site after complete polyp resection.

  • Clip complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence if complications associated with application of clips.


Other Outcome Measures:
  • Factors associated with complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Factors that may be associated with complications, including polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection.

  • Factors associated with incomplete resection or recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1020
Study Start Date: April 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clip closure
Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using the clip (Resolution II clip).
Device: Resolution II clip
Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips. The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips.
No Intervention: No clip closure
No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936948

Contacts
Contact: Heiko Pohl, MD 802-295-9363 ext 5595 heiko.pohl@dartmouth.edu
Contact: Cathy Lombardo 802-295-9363 ext 6957 cathy.lombardo@va.gov

Locations
United States, Vermont
White River Junction VAMC Recruiting
White River Junction, Vermont, United States, 05009
Contact: Heiko Pohl, MD    802-295-9363 ext 5595    heiko.pohl@dartmouth.edu   
Contact: Cathy Lombardo    802-295-9363 ext 6957    cathy.lombardo@va.gov   
Principal Investigator: Heiko Pohl, MD         
Sponsors and Collaborators
White River Junction VAMC
Center for Bioinformatics at Geisel School of Medicine at Dartmouth
Investigators
Study Chair: Heiko Pohl White River Junction VAMC, Geisel School of Medicine at Dartmouth
  More Information

No publications provided

Responsible Party: Dr. Heiko Pohl, Principal Investigator, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT01936948     History of Changes
Other Study ID Numbers: CPHS-23578
Study First Received: September 3, 2013
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by White River Junction VAMC:
Large colon polyps
Polyp resection
Colon cancer screening
Colonoscopy
Endoscopic mucosal resection

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on October 01, 2014