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.
|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.|
- 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.
- 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.
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936948
|Contact: Heiko Pohl, MD||802-295-9363 ext email@example.com|
|Contact: Cathy Lombardo||802-295-9363 ext firstname.lastname@example.org|
|United States, Vermont|
|White River Junction VAMC||Recruiting|
|White River Junction, Vermont, United States, 05009|
|Contact: Heiko Pohl, MD 802-295-9363 ext 5595 email@example.com|
|Contact: Cathy Lombardo 802-295-9363 ext 6957 firstname.lastname@example.org|
|Principal Investigator: Heiko Pohl, MD|
|Study Chair:||Heiko Pohl||White River Junction VAMC, Geisel School of Medicine at Dartmouth|