TerminatedPhase 2ACTRN12613000720718

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

For patients with non lifting polyps, is Hot Avulsion versus Argon Plasma Coagulation for removal of residual polyp tissue more effective.


Sponsor

Dr Spiro Raftopoulos

Enrollment

160 participants

Start Date

Jul 8, 2013

Study Type

Interventional

Conditions

Summary

Endoscopic management of large colonic polyps is an increasingly utilised and accepted alternative to surgery. Complete polyp removal after a single treatment session is high with a recent prospective study reporting first-time success in 84% of patients presenting for endoscopic management. The success rate of first time complete polypectomy is significantly lower when the lesion cannot be fully excised utilising a standard injection and snare technique. This is more common in large rectal polyps, polyps that have undergone partial or incomplete resection, and polyps that have been marked with SPOT tattoo. All these scenarios result in submucosal fibrosis and therefore failed lift with standard submucosal injection. In this setting the traditional approach has been to resort to ablative techniques such as argon plasma coagulation (APC) and snare tip coagulation (STC), however the use of APC has been identified as a risk factor for residual adenoma at follow-up colonoscopy with a recent study showing an increase in residual adenoma at follow-up from 17.5 to 39.5% (RR 2.25; 1.45-3.50, p=0.002). Recently, the use of hot avulsion (HA) has been shown in a prospective pilot study, to be a safe and highly effective technique for dealing with difficult non-lifting polyps (NLP). Currently there is no published literature to guide effective management of the NLP. The proposed study design is a randomised clinical trial comparing HA to APC (the current standard of care) for the management of polyps that fail removal using a standard snare resection technique. We postulate that HA will result in a significantly higher rate of complete polyp removal of the non-lifting polyp when compared to standard therapy. Patients undergoing colonoscopy for removal of large polyps (>20mm), polyps that have failed previous resection, polyps that have previously been injected with SPOT tattoo or patients presenting for follow-up of previously removed large polyps will be approach for inclusion in the study. Following commencement of polypectomy, if the endoscopist fails to remove the polyp entirely using standard snare techniques, they will be randomised to either HA or standard of care (APC). The primary outcome measure of this study is the rate of macroscopic and histologic eradication of neoplasia at the first follow up colonoscopy which is routinely performed at 4 months. The outcome variable is dichotomous (residual or no residual) and will be expressed as a proportion. If patients fail removal at first follow-up, a second treatment will be attempted. If at the second follow-up there is persistent polyp, this will be considered a treatment failure and the treating physician will then be able to either cross arms or refer the patient for surgical management.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • 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
  • Any polypectomy case where there remains visible neoplastic tissue after attempts at standard snare resection by an expert Endoscopist
  • Aged 18 years or above
  • Patient able to give signed Informed consent

Exclusion Criteria6

  • Any condition that precludes the patient from undergoing colonoscopy eg. severe co-morbidities, pregnancy
  • 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
  • Patients with known severe coagulopathy (INR > 2.0), bleeding diathesis or severe thrombocytopenia (platelet count < 50,000)
  • Patients in whom complete snare resection is possible
  • Polyp not deemed endoscopically resectable
  • Polyps with endoscopic features concerning for sub-mucosal invasion as assessed by an expert Endoscopist

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Interventions

Hot Avulsion is an endoscopic technique, which involves mechanical electrocoagulation and resultant avulsion of neoplastic tissue using a standard hot biopsy forceps. This will be performed using

Hot Avulsion is an endoscopic technique, which involves mechanical electrocoagulation and resultant avulsion of neoplastic tissue using a standard hot biopsy forceps. This will be performed using a Hot Biopsy forceps by Boston Scientific or Olympus. The neoplastic tissue will be grasped in the forceps and then preferentially, EndoCut I (ERBE VIO 200/300, Effect 2/Timing 2/Other 3) will be delivered using a tapping technique. If neoplastic tissue does not avulse with application of current, gentle mechanical traction will be applied away from the bowel wall. In centres with older electrocautry systems (ERBE ICC 200), coagulation (Soft coagulation, 80 W) will be used instead with gentle mechanical traction away from the bowel wall. This process will be continued until all neoplastic tissue has been removed as deemed by the treating physician.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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