Hot avulsion versus argon plasma coagulation for the management of the non-lifting polyp: a multicentre, randomised controlled trial

Phase 2

• Conditions: Colonic Polyps; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000720718
• Lead Sponsor: Dr Spiro Raftopoulos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-01
• Study Completion: 2018-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Referral for colonoscopic polyp (>= 20mm) removal or attending follow-up colonoscopy following complete or incomplete polyp removal and this deemed appropriate by a consultant gastroenterologist
2.Any polypectomy case where there remains visible neoplastic tissue after attempts at standard snare resection by an expert Endoscopist
3.Aged 18 years or above
4.Patient able to give signed Informed consent

Exclusion Criteria

1.Any condition that precludes the patient from undergoing colonoscopy eg. severe co-morbidities, pregnancy
2.Patients having received Coumadin preparations, Clopidogrel within the prior 7 days, therapeutic dose of unfractionated heparin within 6h, low-molecular weight heparin within 12 h, or Dabigatran within the prior 2 days
3.Patients with known severe coagulopathy (INR > 2.0), bleeding diathesis or severe thrombocytopenia (platelet count < 50,000)
4.Patients in whom complete snare resection is possible
5.Polyp not deemed endoscopically resectable
6.Polyps with endoscopic features concerning for sub-mucosal invasion as assessed by an expert Endoscopist

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of macroscopic and histologic eradication of neoplasia at the first follow up colonoscopy.[12 months]

Secondary Outcome Measures

Name	Time	Method
The rate of macroscopic and histological eradication at 12 months[12 months];Number of procedures required to achieve eradication[At completion];Procedural complications (immediate and delayed bleeding, perforation, and serositis) occurring within 14 days of the polypectomy and cost[Within 14 days of polypectomy];Cost data abstraction sheets using pertinent data from outpatient and hospital records will be designed to determine the direct costs attributable to each arm. The calculation will consist of summing the costs of all endoscopy visits, laboratory, imaging, and complication-related treatment following randomisation for events whose onset is within a 14-day window after randomisation. Costs attributable to hospital stay and related in-hospital testing will also be recorded.[At completion]