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Completed

NCT Number: NCT05117879

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan (roc), 100, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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。

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. R0 resection rate

    Time frame: within 14 days

    The margin of the resected specimen showed no adenoma involvement

Secondary outcomes

  1. Mean polypectomy time

    Time frame: within 1 hour

    Total time spent for polypectomy and hemostasis technique

  2. Successful tissue retrieval

    Time frame: 1 hour

    The rate of successful tissue retrieval after polypectomy

  3. Mean number of cuts

    Time frame: 1 hour

    How many cuts to remove the lesion

  4. En bloc resection

    Time frame: 1 hour

    The rate of en bloc resection

  5. Cut number

    Time frame: 1 hour

    how many cuts to remove the lesion

  6. Mean total procedure time

    Time frame: 1 hour

    The total time of the colonoscopy, including polypectomy or EMR

  7. Emergency service visit

    Time frame: within 14 days

    Patient visit ER after polypectomy for any complication

  8. Delayed bleeding rate

    Time frame: within 14 days

    Bleeding occurs delayed from several hours to weeks after the polypectomy

  9. Perforation rate

    Time frame: two weeks

    perforation after polypectomy or EMR

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 11, 2021
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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