Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal

Colorectal Polyps Clinical Trial

— BIOPANS  

Official title:

Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04727918
• Other study ID #: SFED 105
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: July 3, 2020

Study information

• Verified date: January 2021
• Source: French Society of Digestive Endoscopy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 3, 2020
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Routine colonoscopy

• Patient older than 18 years

• at least one polyp measuring = 5 mm

Exclusion Criteria:

• inflammatory bowel disease

• polyposis syndrome, pregnancy

• inability to provide informed consent

Related Conditions & MeSH terms

• Colorectal Polyps
• Polyps

Intervention

Procedure:
• Polypectomy of diminutive colorectal polyps will be performed by CBF
All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CBF : The CBF will be performed using a standard biopsy forceps (Gluton Life ® Life Partners). Multiple biopsies bites were taken until complete resection (as many as needed).
• Polypectomy of diminutive colorectal polyps will be performed by CSP
All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CSP : The CSB procedure will be performed using a 9 mm cold snare (Exacto ® Life Partners). One to two mm of normal surrounding mucosa will be ensnared around the base of the polyp, followed by mechanical excision without electrocautery

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou 20, rue Leblanc	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Gabriel RAHMI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination.	Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site	through study completion, an average of 2 years.
Secondary	Specimen retrieval rate (% time of polypectomy)	specimen will be immediately suctioned into the operating channel.	through study completion, an average of 2 years.
Secondary	Procedure time ( overall time between introduction and removal of colonoscope)	measure of the time until complete polyp resection is obtained	through study completion, an average of 2 years.
Secondary	Procedure related adverse events will be collected (adverse events : %, number of event for each groupe) during the procedure or during the follow up period (28 days).	perforation, gastrointestinal and bleeding	All patients will be followed-up until 28 days post-colonoscopy.