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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05117879
Enrollment
120
Registered
2021-11-11
Start date
2020-12-10
Completion date
2024-01-15
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual Disease

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.

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

Interventions

PROCEDURECold 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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..)

Design outcomes

Primary

MeasureTime frameDescription
R0 resection ratewithin 14 daysThe margin of the resected specimen showed no adenoma involvement

Secondary

MeasureTime frameDescription
Successful tissue retrieval1 hourThe rate of successful tissue retrieval after polypectomy
Mean number of cuts1 hourHow many cuts to remove the lesion
En bloc resection1 hourThe rate of en bloc resection
Cut number1 hourhow many cuts to remove the lesion
Mean polypectomy timewithin 1 hourTotal time spent for polypectomy and hemostasis technique
Emergency service visitwithin 14 daysPatient visit ER after polypectomy for any complication
Delayed bleeding ratewithin 14 daysBleeding occurs delayed from several hours to weeks after the polypectomy
Perforation ratetwo weeksperforation after polypectomy or EMR
Mean total procedure time1 hourThe total time of the colonoscopy, including polypectomy or EMR

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026