Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size

NCT02354287 | Completed DMC

• 1 other identifier: 166725
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the American Society of Gastrointestinal Endoscopy have guidelines for the removal of these polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy are diminutive to small. Multiple techniques are used for polyp removal, especially diminutive lesions. These include either forceps, both hot and cold, as well as snare with electrocautery or cold snare. Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a current through the grasper to essentially burn tissue. Snare is the use of a small metal loop placed and tightened at the base of polyps to cut through the tissue either straight away in a cold method or with electrocautery where a small current is passed through the loop to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in Australia and the United States show that the choice of method used for diminutive to small polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy techniques are limited and it is clear that additional data and the review of polypectomy methods needs to be undertaken in order determine the optimal method for the removal of diminutive and small colorectal polyps. A technique is used at the Gloucestershire National Health Service (NHS) trust involving a submucosal pre injection with a standard solution then the use of cold forceps for removal of polyps ≤7mm. This appears to be both very safe and highly effective method for the removal of these lesions compared to other techniques. No formal published studies have been completed to evaluate this method at national and international levels. We propose a study to evaluate the effectiveness, safety and costs of this method.

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• Histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps ≤7mm.

  Gastrointestinal pathologist will assess histology of polyp resected then assess the polypectomy site rim that was resected at EMR for any evidence of residual polyp that was not visible to the colonoscopist.

  Within one week of patients colonoscopy

Secondary Outcomes (1)

• The number of bites required for complete visual resection of these polyps and the time taken from the beginning of pre injection needle insertion till complete resection.

  intraoperative during colonoscopy and analysed within one month of last patient recruitment

Other Outcomes (3)

• The polyp retrieval rate of this method.

  intraoperative during patient colonoscopy and analysed within one month of last patients recruitment.

• Immediate or delayed complications from this technique.

  intraoperative and after one week.

• An overall comparison of this polypectomy method compared to other methods used for diminutive and small polyps.

  2 months post completion of recruitment.

Study Arms (1)

Patients having outpatient Colonoscopy.

Patients with Polyps ≤7mm that are deemed appropriate to be removed by cold forceps polypectomy with pre lift

Procedure: Cold forceps polypectomy with pre lift

Interventions

Cold forceps polypectomy with pre lift PROCEDURE

Polyps ≤7mm will be included in the study if deemed appropriate by the colonoscopist.. These polyps will be resected with cold forceps after pre injection into the submucosa with a few millilitres of pre injection solution (19 ml gelofusine, 1ml 1:10000 adrenaline and 1ml indigo carmine). Polyps are grasped with the cold forceps and pulled away from the rest of the colonic mucosa. Attempt will be made to remove polyps with single attempt with the forceps however several grasps may be required for complete visual resection of the polyp. The polypectomy site and a 5mm rim of normal appearing tissue will then be resected with endomucosal resection (EMR) using conventional snare method. This is to ascertain if there is any residual polyp tissue.

Also known as: polypectomy

Patients having outpatient Colonoscopy.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents from within Gloucestershire, United Kingdom whom have been referred for a Colonoscopy through either. 1. Bowel cancer screening program or outpatient referral 2. Outpatient clinics 3. Inpatient referral

You may qualify if:

• Patients from Cheltenham General Hospital and Royal Gloucestershire Hospitals that have been scheduled for colonoscopy through our outpatient clinics or inpatient consult service will be prospectively recruited prior to their Colonoscopy.

You may not qualify if:

• Patients will be excluded if:
• They are under the age of 18.
• They do not have capacity to consent for the Colonoscopy as determined at the time of procedural admission by the trained admitting endoscopy nurse. If a patient is deemed to lack capacity by the referring doctor or admitting nurse this will also be assessed by the colonoscopist. Both the colonoscopist and admitting nurses have been trained to assess capacity,that is whether a persons mind is affected at the time of the procedure in such a way that they are unable to make a decision. There are multiple reasons as to why an individuals brain or mind may be altered such as medications, mental illness or dementia.
• There is a history of Inflammatory Bowel Disease
• Identified coagulopathy with PT\>1.4 or thrombocytopenia with Platelets \<80 on any bloods collected within routine clinical practice within the past 4 weeks. This will not be an additional procedure and these bloods are routinely taken on patients where coagulopathy or thrombocytopenia is a concern such as patients on long term Warfarin or with chronic liver disease. These patients are identified by Endoscopy nursing staff in pre assessment work up. Routine haematology is not taken as part of a standard assessment for outpatient endoscopy.
• Taking dual anti platelet therapy or pharmacological anti coagulation.
• Bowel preparation is deemed poor by colonoscopist.

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead
• Olympus: collaborator

Study Sites (1)

Cheltenham General Hospital

Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

Location

Related Publications (24)

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Study Officials

• Sam A O'Connor, FRACP

  Advanced Endoscopy and Gastroenterology Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 3, 2015
• Study Start: February 1, 2015
• Primary Completion: September 25, 2015
• Study Completion: September 25, 2015
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

GB (1)