Cold Snare,Hot Snare and APC Polypectomy for the Complete Removal of Small Left Sided Colon Polyps

May 7, 2020 updated by: Nikos Viazis, Evangelismos Hospital

Cold Snare Polypectomy vs Hot Snare Polypectomy vs APC for the Complete Removal of Left Sided Colon Polyps. A Prospective,Randomized Trial

Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a diameter of 0.8cm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adenomatous polyps are the most common neoplastic findings discovered in subjects who undergo colonoscopy either for colorectal screening or during a diagnostic work-up for symptoms.

Currently small polyps 0.3-0.8cm are removed using hot snare polypectomy (HSP) cold snare polypectomy (CSP) while argon plasma coagulation (APC) has been proposed for the cauterization of bigger polyps ("Melt Effect") Endoscopic polypectomy is associated with potential complications, i.e. perforation and bleeding while some polyps may recur after polypectomy.

Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare the above mentioned methods for the compete removal of colonic polyps 0,3-0,8 cm from the left side colon.

METHODS The study will be conducted in the endoscopy unit of "Evangelismos" Hospital and in D Surgical clinic of the University Hospital "Attikon".All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm will be prospectively randomized to three groups.

  1. CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP.
  2. HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function.
  3. APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min.

All polyps will be elevated by submucosal injection of normal saline (1ml) and consequently a special dye (1ml) containing carbon particles (Spot) before applying any of the three removal techniques.

The injection solution protects from thermal injury of deeper layers during the application of current and APC,also the injection of the dye (tattoo) at the polypectomy, ensures that the endoscopist will detect the point of polypectomy in the follow up colonoscopy after 3-6 months.

Spot (GI supply,Camp Hill,PA) is the only commercially available suspension for endoscopic tattooing approved by the Food and Drug Association (FDA). It contains prediluted sterile syrings that are filled with highly purified fine carbon particles ready for endoscopic use.

The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).

Statistical analysis showed that the sample required to give medium (W = 0.3) the difference between the three groups is 108 patients, with significance level of 5% and validity of the study 80% All patients included in the study will undergo a repeat colonoscopy in a 3-6 month time period. The endoscopist based on tattoos have been received on the first endoscopy during polypectomy will receive multiple biopsies from the point, which will be sent for histological examination.The pathologist will then examine the tissue sample and will define whereas the polyp has been completely eradicated or recurred.

Study Type

Observational

Enrollment (Actual)

108

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

    • Attiki
      • Athens, Attiki, Greece, 10676
        • Evangelismos 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

Sampling Method

Non-Probability Sample

Study Population

All patients with colonic left sided small polyps

Description

Inclusion Criteria:

  • All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm.

Exclusion Criteria:

  • The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cold snare polypectomy
CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP.
Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.
Other Names:
  • sigmoidoscopy
  • colonoscopy
hot snare polypectomy
HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function.
Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.
Other Names:
  • sigmoidoscopy
  • colonoscopy
APC polyp destruction-polypectomy
APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min,as result the polyp destruction.
Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.
Other Names:
  • sigmoidoscopy
  • colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete removal of colonic polyps
Time Frame: at 6 months after polypectomy
The resections margin of the polyp was isolated from the rest of the polyp,stained with black and examined through multiple histological sections in order to certify that no dysplastic cells were traced upon the resection margin.Since all adenoma cases exhibited low grade epithelial dysplasia, as positive margin was considered the presence of dysplastic cell exactly upon the resection margin/black ink.
at 6 months after polypectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Nikos Viazis, Director, Evangelismos Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 21, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 80/30-04-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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