- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188316
Comparison of Jumbo and Hot Biopsy Forceps
July 10, 2014 updated by: Bulent Yasar, Camlıca Erdem Hospital
The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps
- Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still widely used methods for endoscopic resection of diminutive colorectal polyps (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of DCPs because of their larger size.
- This was a prospective study of consecutive patients undergoing colonoscopy and found to have at least one diminutive polyp. One experienced endoscopist removed DCPs using either jumbo or hot biopsy forceps.
- Aim was to evaluate the histological quality and adequacy of the DCPs resected using jumbo forceps in comparison with HBF.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Exclusion criteria were (i) having abnormal coagulation parameters and thrombocytopenia, taking aspirin or other medications which could affect bleeding time, (ii) history of inflammatory bowel disease, (iii) pregnancy.
- One experienced endoscopist carried out all the procedures using the same techniques.
- If a diminutive polyp was detected during colonoscopy, and it was estimated that the polyp was eligible for the study, the patient was randomly assigned by the physician to one of the two forceps groups (hot biopsy versus jumbo forceps) using a flipping coin method. Polypectomy was then performed with the intention to remove all polypoid tissue with one forceps bite. After the initial bite was obtained, the polypectomy site was observed with visual inspection. If residual polypoid tissue was observed after the first bite, additional biopsies were taken until visual eradication was attained.
- The size of the polyp was estimated during colonoscopy by visual comparison with the open biopsy forceps (Open-biopsy forceps technique). Polypectomies were performed using jumbo forceps (Conmed, USA) and hot biopsy forceps (Wilson-Cook Medical, USA). For HBF, the technique was based on the procedure first described in 1973, as follows: slight pulling force was applied to the polyp and then the electrocautery current was applied until the white coagulum was seen at the polyp base. The technique for jumbo forceps was as follows: after initial grasping, slight force was applied until the polyp was separated from the stalk. The electrocautery current waveform and intensity settings were the same for each patient. Each biopsy specimen was placed in a separate formalin solution.
- An experienced blinded pathologist evaluated the tissue samples for depth of specimen, amount of cautery damage (for hot biopsy forceps) or crush artifacts (for jumbo forceps), architecture, fragmentation, overall diagnostic quality, evaluation and positivity of surgical margins.
- All statistical analyses were performed using SPSS for Windows v. 15 (SPSS Inc., Chicago, IL, USA). Demographic, biochemical and histopathological features were classified as continuous or categorical variables. Kolmogorov-Smirnov analysis was used to test for Gaussian distribution. The data were expressed as arithmetic mean ± standard deviation (SD), since the evaluated variables were Gaussian-distributed. Comparisons between two groups were performed using the Student's t-test for continuous variables. Categorical variables were compared using the χ2 test (2X2, 3X2 and 4X2 tables) and Fisher's exact test. When the chi-square test was used, Yates' correction for continuity was used. All reported p-values were two-tailed, and those less than 0.05 were considered to be statistically significant.
Study Type
Interventional
Enrollment (Actual)
179
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34660
- Camlıca Erdem Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients found to have at least one diminutive polyp (measuring ≤ 5 mm).
Exclusion Criteria:
- Having abnormal coagulation parameters and thrombocytopenia
- Taking aspirin or other medications which could affect bleeding time
- History of inflammatory bowel disease
- Pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Jumbo forceps polypectomy
89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy.
|
comparison of different polypectomy devices
Other Names:
|
Active Comparator: Hot biopsy electrocauterization
90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization.
|
comparison of different polypectomy devices
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete eradication of diminutive polyps.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adequate histopathological diagnosis
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 10, 2014
First Posted (Estimate)
July 11, 2014
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
July 10, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HNEAH-KAEK 2014/22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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