Clinical trial NCT01789749: Soft Coagulation for the Prevention of Adenoma Recurrence
Official title: Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Adenomas
Keywords: snare tip soft coagulation
endoscopic mucosal resection
adenoma recurrence
adenoma
colonoscopy
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.


Eligibility criteria: Inclusion Criteria:

* Referred for removal of a colonic polyp \>= 20mm in size
* Able to give informed consent to involvement in trial

Exclusion Criteria:

* Younger than 18 years of age
* Highly dependant on medical care
* Women who are pregnant or may be pregnant.
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder
* Previous attempt at EMR of the polyp referred for resection
* Polyp located at the ileo-caecal valve, appendiceal orifice
* Fully circumferential polyp
* Incomplete snare resection of the polyp

Primary outcomes:
measure: Endoscopic recurrence
timeFrame: 4-6 months and 18 months
Secondary outcomes:
measure: Histologic recurrence
timeFrame: 4-6 months and 18 months
measure: En bloc resection
timeFrame: Index procedure
measure: Snare resections
timeFrame: Index procedure
measure: Duration
timeFrame: Index procedure
measure: Perforation during EMR
timeFrame: During index procedure
measure: Post EMR bleeding
timeFrame: Post Index procedure
measure: Number of injections for hemostasis
timeFrame: Index procedure, if post EMR bleeding
measure: Location of bleeding vessels
timeFrame: Index procedure, if post EMR bleeding
measure: Size/number of bleeding vessels
timeFrame: Index procedure, if post EMR bleeding
measure: Delayed perforation
timeFrame: After index procedure
measure: Readmission
timeFrame: After index procedure
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: VA
Study officials:
affiliation: Western SLHD
name: Michael Bourke, FRACP, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.