NCT03783156: Polypech-c

Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

Completed NA Last updated 13 May 2020

What this trial tests

NA trial testing hot snare in Polyp of Colon in 300 participants. Completed in 31 December 2019.

Timeline

18 February 2019

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Hospital del Rio Hortega
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	18 February 2019
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• hot snare
• cold snare

Conditions studied

• Polyp of Colon — all drugs for Polyp of Colon →
• Gastrointestinal Bleeding — all drugs for Gastrointestinal Bleeding →
• Colonic Adenoma — all drugs for Colonic Adenoma →

Sponsor

Hospital del Rio Hortega

Who can join

18 and older, any sex, with Polyp of Colon or Gastrointestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.