Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03865537
Other study ID # 119681
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date January 2027

Study information

Verified date June 2024
Source White River Junction Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.


Description:

Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection. Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 990
Est. completion date January 2027
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any patient =18 who presents for a colonoscopy and who does not have criteria for exclusion - Patients with a =20mm non-pedunculated colorectal polyp Exclusion Criteria: - Pedunculated polyps (as defined by Paris Classification type Ip) - Suspected adenocarcinoma with deep submucosal invasion - Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma - 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 - Inadequate bowel preparation (Boston Bowel Prep Scale, total score =2) - Pregnancy

Study Design


Intervention

Procedure:
Cold snare EMR
Participants will have their large polyp removed without electrocautery
Hot snare EMR
Participants will have their large polyp removed with electrocautery
Eleview injection
Participants will have their polyp submucosally injected with Eleview
Placebo injection
Participants will have their polyp submucosally injected with placebo

Locations

Country Name City State
United States White River Junction VAMC White River Junction Vermont

Sponsors (4)

Lead Sponsor Collaborator
White River Junction Veterans Affairs Medical Center Cosmo Pharmaceuticals, Dartmouth College, Steris

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severe Adverse Events Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure up to 30 days following the procedure
Secondary Subcategories of severe adverse events Bleeding, post-polypectomy syndrome, perforation, abdominal pain during the procedure and up to 30 days following the procedure
Secondary Performance submucosal injectate Injection performance immediately following polyp resection during the colonoscopy
Secondary Volume of submucosal injectate volume of injection immediately following polyp resection during the colonoscopy
Secondary Efficacy of submucosal injectate Sidney index immediately following polyp resection during the colonoscopy
Secondary Completeness of polyp resection Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist. immediately following polyp resection during the colonoscopy
Secondary Intraprocedural bleeding bleeding that requires endoscopic intervention to stop the bleeding at the time of polyp resection
Secondary Polyp recurrence Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection at surveillance colonoscopies up to 5 years following the initial polyp resection
Secondary Crossover from cold to hot snare Proportion of polyps in the cold snare group that could not be removed by cold snare and were removed by hot snare, categorized by size and morphology subtypes of polyps at the time of polyp resection
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A