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

Sponsor

Western Sydney Local Health District (Other)

Overall Status

Recruiting

CT.gov ID

NCT02967107

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Adenoma	Procedure: Cold snare polypectomy Procedure: Endoscopic mucosal resection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cold snare polypectomy Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm	Procedure: Cold snare polypectomy Use of a polypectomy snare closed over a polyp without electrocautery Other Names: CSP
Active Comparator: Endoscopic mucosal resection Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm	Procedure: Endoscopic mucosal resection Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery Other Names: EMR

Arm

Intervention/Treatment

Active Comparator: Cold snare polypectomy

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

Procedure: Cold snare polypectomy

Use of a polypectomy snare closed over a polyp without electrocautery

Other Names:

CSP

Active Comparator: Endoscopic mucosal resection

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

Procedure: Endoscopic mucosal resection

Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery

Other Names:

EMR

Outcome Measures

Primary Outcome Measures

Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy [4-6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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