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

Residual Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117879
• Other study ID #: 202008004RINC
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: Li-Chun Chang, PhD
• Phone: 02-23123456
• Email: lichunchang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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..)

Related Conditions & MeSH terms

• Residual Disease

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Taiwan (roc)

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	The margin of the resected specimen showed no adenoma involvement	within 14 days
Secondary	Delayed post-polypectomy bleeding	Bleeding occurs delayed from several hours to weeks after the polypectomy	within 14 days
Secondary	Immediate post-polypectomy bleeding	Bleeding occur immediately after the polypectomy	within 24 hours
Secondary	Bowel perforation rate	Bowel perforation occurs after colonoscopy	within 14 days
Secondary	Number of hemoclips per polypectomy	Total number of hemoclips used after each polypectomy for hemostasis	within 1 hour
Secondary	Emergency department visit	Patient visit ER after polypectomy for any complication	within 14 days
Secondary	Procedure time	Total time spent for polypectomy and hemostasis technique	within 1 hour