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Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps (CSP-EMR)

Primary Purpose

Colorectal Cancer, Adenoma

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Cold snare polypectomy
Endoscopic mucosal resection
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenoma, colorectal cancer, polypectomy, colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications
  • Age > 18 years
  • At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy
  • At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR

Exclusion Criteria:

  • Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines [21]
  • Known coagulopathy
  • Pregnancy
  • If any doubt about the morphology of the polyp, the patient will be excluded from the study

Sites / Locations

  • Westmead Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cold snare polypectomy

Endoscopic mucosal resection

Arm Description

Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm

Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm

Outcomes

Primary Outcome Measures

Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy

Secondary Outcome Measures

Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
Pain after EMR

Full Information

First Posted
August 13, 2016
Last Updated
June 27, 2023
Sponsor
Western Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT02967107
Brief Title
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps
Acronym
CSP-EMR
Official Title
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection
Detailed Description
Colorectal cancer (CRC) is the third most common cancer and it remains the second most commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has proven to be effective in reducing mortality and morbidity from CRC and has become common practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy) occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete adenoma resection. The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor lesions are thought to be a major contributor to the relative failure of colonoscopy in the prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the period after complete colonoscopy and prior to surveillance, termed 'interval' cancer. In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas, and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have indistinct margins, and smaller lesions may prove difficult to entrap with the snare because of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an endoscopic appearance indistinguishable from conventional adenomas, and the surrounding serrated component may be overlooked and incompletely resected if this is not recognized. The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes with regard to polyp detection rate, complete resection rate (CRR) of polyps, patient comfort, safety and cost-efficacy. Although colonoscopy is considered the 'gold standard' for detecting and removing polyps, the technique is still imperfect. Questions about best practice for polypectomy remain, so optimizing the technique is expected to lead to better patient outcomes. The optimal treatment of SSPs should be effective, safe and inexpensive. Such lesions can be removed by cold snare polypectomy or by endoscopic mucosal resection. Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of any small polyps (<10 mm). Because of their physical characteristics, use of thin wire snares leads to a fast tissue transection and ability to remove SSP relatively swiftly. The size of snares suitable for SSP CSP is approximately 9 mm. Thus lesions greater than this size would need to be removed in more than one piece, introducing the possibility of incomplete resection. Endoscopic mucosal resection (EMR) is well established for laterally spreading colorectal lesions. It involves submucosal injection and diathermy assisted snare resection by piecemeal or en-bloc depending on polyp size. En bloc resection is possible for lesions up to 20 mm and facilitates histopathological evaluation. EMR is more time consuming than CSP and may be associated with diathermy related complications such as postpolypectomy bleeding, perforation and pain. The most efficient and safe method of removal of SSP has not been established.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenoma
Keywords
adenoma, colorectal cancer, polypectomy, colonoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold snare polypectomy
Arm Type
Active Comparator
Arm Description
Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
Arm Title
Endoscopic mucosal resection
Arm Type
Active Comparator
Arm Description
Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
Intervention Type
Procedure
Intervention Name(s)
Cold snare polypectomy
Other Intervention Name(s)
CSP
Intervention Description
Use of a polypectomy snare closed over a polyp without electrocautery
Intervention Type
Procedure
Intervention Name(s)
Endoscopic mucosal resection
Other Intervention Name(s)
EMR
Intervention Description
Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
Primary Outcome Measure Information:
Title
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
Time Frame
2 weeks
Title
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
Time Frame
2 weeks
Title
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
Description
Pain after EMR
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications Age > 18 years At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR Exclusion Criteria: Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines [21] Known coagulopathy Pregnancy If any doubt about the morphology of the polyp, the patient will be excluded from the study
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps

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