CompletedNCT01936948Updated Jul 12, 2024Results posted

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

An interventional study of Clip closure in Colon Polyps, sponsored by White River Junction Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by White River Junction Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Apr 2013, registered Sep 2013).

Phase: Not applicable
Study type: Interventional
Enrollment: 928
Allocation: Randomized
Ages: 18 Years to 89 Years
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Colon Polyps

Browse trials for

Colonic Polyps 377

Keywords

Large colon polyps
Polyp resection
Colon cancer screening
Colonoscopy
Endoscopic mucosal resection

In context

Colonic Polyps

377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.

This study's enrollment of 928 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

White River Junction Veterans Affairs Medical Center is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 89 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with known ( 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 (>3)
Patients with coagulopathy with an elevated ≥1.5, or \<50
Poor bowel preparation
Pregnancy

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 928 participants (actual)

Study arms

Active comparator
Clip closure + EndoCut
Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.
Procedure: Clip closure
Active comparator
Clip closure + Coagulation
Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.
Procedure: Clip closure
No intervention
No clip closure + EndoCut
No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
No intervention
No clip closure + Coagulation
No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.

Interventions

ProcedureClip closure
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.

What researchers measure

Primary outcomes

Number of Participants With Delayed Bleeding Complications
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.
Time frame: 30 days following a study polyp resection

Secondary outcomes

The Overall Number of Complications
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.
Time frame: 30 days
Complete Study Polyp Resection Rate
Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy
Time frame: 6 months
Polyp Recurrence Rate
Rate of recurrent polyp at the resection site after complete polyp resection.
Time frame: 3 months to 5 years
The Number of Complications Associated With Clip Use
Incidence of complications associated with application of clips.
Time frame: 30 days

Other outcomes

Measured Factors Associated With Resection Complications
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.
Time frame: 30 days
Measured Factors Associated With Incomplete Resection or Recurrence of Polyps
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.
Time frame: 5 years

Results

Posted Jun 22, 2021

Limitations and caveats

Complete defect closure not possible in 13% of patients. Crossover to clip group in 10% of patients.

Participant flow

Participant flow — Overall Study
Milestone	Clip Closure + EndoCut	Clip Closure + Coagulation	No Clip Closure + EndoCut	No Clip Closure + Coagulation
Started	227	231	237	233
Crossover	31	27	22	25
Completed	227	228	234	230
Not completed	0	3	3	3
Withdrew: No 30-day follow-up data	0	3	3	3

Outcome measures

PrimaryNumber of Participants With Delayed Bleeding Complications

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.

Time frame:: 30 days following a study polyp resection
Reported as:: Count of participants · Participants

Number of Participants With Delayed Bleeding Complications
Participants	Clip Closure	No Clip Closure
Number of Participants With Delayed Bleeding Complications	16	33

SecondaryThe Overall Number of Complications

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.

Time frame:: 30 days
Reported as:: Count of participants · Participants

The Overall Number of Complications
Participants	Clip Closure	No Clip Closure
The Overall Number of Complications	22	44

SecondaryComplete Study Polyp Resection Rate

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

Time frame:: 6 months