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

Comparison of R0 Resection Rate Between Cold Snare Polypectomy, Cold Endoscopic Mucosal Resection and Hot Endoscopic Mucosal Resection for 1-2 cm Colorectal Sessile Serrated Lesions: a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Residual Disease
• Intervention / Treatment: Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR

Detailed Description

This study is a single-country, multi-center, randomized controlled study. The subjects of the case were patients who underwent colonoscopy for various indications and found flat serrated adenomas ranging in size from 10-20 mm during the procedure. Excluded criterias are patients who are younger than 20 years old and have contraindications for colonoscopy. All patients included in the study will sign the informed consent sheet at the outpatient clinic. Once a flat serrated adenoma with a size of 10-20 mm is found during colonoscopy, the subjects will be randomly assigned to Cold snaring polypectomy group, cold endoscopic mucosal resection group or hot endoscopic mucosal resection group.

The preoperative preparation for bowel cleansing and colonoscope insertion method for these three groups of patients are totally the same as those of general colonoscopy. The only difference is the resection method flat serrated glands of 10-20 mm. The tumor was resected by cold snaring polypectomy, one group was resected by cold endoscopic mucosal resection, and the other group was resected by hot endoscopic mucosal resection. The endoscopists participating in this research project have extensive experience in endoscopy and perform at least one hundred polypectomy operations every year. The excised tumor will be sent to the pathology department for pathological diagnosis, and the pathology doctor will judge the completeness of the tumor resection

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan (roc)
    • Taipei, Taiwan (roc), Taiwan, 100
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cold snaring polypectomy; The sessile serrated adenoma size between 10-20mm would be resected by cold snaring polypectomy	Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR; 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.
Other: Non-electrocautery Endoscopic Mucosal Resection (Cold EMR); The sessile serrated adenoma size between 10-20mm would be resected by cold EMR	Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR; 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.
Other: Electrocautery Endoscopic Mucosal Resection( Hot EMR); The sessile serrated adenoma size between 10-20mm would be resected by Hot EMR	Procedure: Cold snaring polypectomy/ Cold EMR/Hot EMR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	The margin of the resected specimen showed no adenoma involvement	within 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean polypectomy time	Total time spent for polypectomy and hemostasis technique	within 1 hour
Successful tissue retrieval	The rate of successful tissue retrieval after polypectomy	1 hour
Mean number of cuts	How many cuts to remove the lesion	1 hour
En bloc resection	The rate of en bloc resection	1 hour
Cut number	how many cuts to remove the lesion	1 hour
Mean total procedure time	The total time of the colonoscopy, including polypectomy or EMR	1 hour
Emergency service visit	Patient visit ER after polypectomy for any complication	within 14 days
Delayed bleeding rate	Bleeding occurs delayed from several hours to weeks after the polypectomy	within 14 days
Perforation rate	perforation after polypectomy or EMR	two weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Han-Mo Chiu, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 202008004RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No