R0 Resection Rate Between CSP, cEMR and hEMR for 1-2 cm Colorectal SSLs

NCT05117879 | Completed DMC

• 1 other identifier: 202008004RINC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the most prevalent cancer and the third cancer related death in Taiwan. Adenoma is a precancerous lesion of colorectal cancer. Using colonoscopy to detect and remove the adenoma has a chance to prevent colorectal cancer development. In the resection of colorectal polyps, for medium and large polyps that are more than one centimeter and less than two centimeters, because these polyps are at risk of cancer, they currently use hot-snaring polypectomy or more advanced endoscopic mucosal resection. Resection of such tumors ensures that a sufficient depth of resection and a high complete resection rate (R0 resection) are achieved. Flat serrated adenoma (sessile serrated lesion) is a special adenoma that accounts for 10-12% of all colorectal polyps. Different from traditional adenomas, flat serrated adenomas within two centimeters in size have very little chance of becoming cancerous. And we know that on removal of medium and large polyps of 10-20mm, compared with the cold snaring polypectomy, the postoperative bleeding of the hot-snaring polypectomy technique is higher. Therefore, when removing low-risk polyps such as flat serrated adenomas, we may choose using a non-energized technique with low complications and we then would like to know whether the complete resection rate can be achieved by using the non-energized technique in the resection of a flat serrated adenoma of 10-20 mm, despite the large size, and compare the success rate and complications with traditional hot snaring polypectomy.

Conditions

Residual Disease

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The margin of the resected specimen showed no adenoma involvement

  within 14 days

Secondary Outcomes (9)

• Mean polypectomy time

  within 1 hour

• Successful tissue retrieval

  1 hour

• Mean number of cuts

  1 hour

• En bloc resection

  1 hour

• Cut number

  1 hour

Study Arms (3)

Cold snaring polypectomy

OTHER

The sessile serrated adenoma size between 10-20mm would be resected by cold snaring polypectomy

Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR

Non-electrocautery Endoscopic Mucosal Resection (Cold EMR)

OTHER

The sessile serrated adenoma size between 10-20mm would be resected by cold EMR

Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR

Electrocautery Endoscopic Mucosal Resection( Hot EMR)

OTHER

The sessile serrated adenoma size between 10-20mm would be resected by Hot EMR

Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR

Interventions

Cold snaring polypectomy/ Cold EMR/Hot EMR PROCEDURE

Cold snaring polypectomy: The technique of cold snare polypectomy is used to remove \[small colonic polyps\] without diathermy, which implies that a polyp is transected by a snare along with a rim of surrounding normal mucosa. Cold EMR: Cold EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal cold snare resection of target polyp with a margin of normal tissue. Hot EMR: Hot EMR technique comprising submucosal injection of succinylated gelatin and dilute methylene blue before piecemeal electrocautery snare resection of target polyp with a margin of normal tissue.

Cold snaring polypectomy; Electrocautery Endoscopic Mucosal Resection( Hot EMR); Non-electrocautery Endoscopic Mucosal Resection (Cold EMR)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 20 years old
• Indicated for colonoscopy and willing to receive colonoscopy examination and polyp resection。
• Any Sessile serrated adenoma size between 10-20mm was found during the examination。

You may not qualify if:

• Age younger than 20 years old
• Contraindication for colonoscopy or polypectomy (Such as recent acute myocardial infarction, pulmonary embolism ,coagulopathy..)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan (roc), 100, Taiwan

Location

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Han-Mo Chiu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Model Details: Three groups: Cold snaring polypectomy, Cold EMR and Hot EMR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 11, 2021
• Study Start: December 10, 2020
• Primary Completion: December 28, 2023
• Study Completion: January 15, 2024
• Last Updated: October 17, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)