None listed
Conditions
Interventions
Procedure/Surgery : The intervention in this study is the timing of the first surveillance colonoscopy after piecemeal endoscopic mucosal resection and margin thermal ablation for large nonpedunculate
Sponsors
Yonsei University, Wonju Severance Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged 19 years or older. (2) Participants who understand the purpose and procedures of this clinical trial and voluntarily provide written informed consent to participate. (3) Participants who are able to attend scheduled visits, including the planned surveillance colonoscopy, and who are willing and able to comply with the study procedures. (4) Participants in whom a large nonpedunculated colorectal polyp (LNPCP) measuring 20 mm or larger is identified on colonoscopy and for whom piecemeal endoscopic mucosal resection (pEMR) is planned, or participants in whom such a lesion is incidentally detected during routine colonoscopy and successfully removed on the same day by pEMR and snare tip soft coagulation (STSC) without any visible residual lesion. (5) Participants with a nonpedunculated colorectal polyp detected on colonoscopy. (6) Lesions with a maximum diameter of 20 mm to 50 mm, as assessed endoscopically before pEMR using an open snare of known size as a reference. (7) Lesions completely resected by piecemeal endoscopic mucosal resection (pEMR), with no endoscopically visible residual lesion at the end of the procedure. (8) Resected lesions with a histologic diagnosis other than colorectal cancer and meeting one of the following criteria: - Conventional adenoma: tubular adenoma or tubulovillous adenoma without high-grade dysplasia. - Serrated lesion: hyperplastic polyp or sessile serrated lesion (SSL) without high-grade dysplasia.
Exclusion criteria
Exclusion criteria: (1) Patients with a confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn’s disease. (2) Patients with a confirmed or suspected hereditary polyposis or nonpolyposis syndrome, including: - Familial adenomatous polyposis (FAP) - MUTYH-associated polyposis syndrome - Juvenile polyposis syndrome - Cowden syndrome - Peutz-Jeghers syndrome - Hereditary nonpolyposis colorectal cancer (HNPCC) or Lynch syndrome (3) Patients who clinically require an additional colonoscopy within 12 months after the index colonoscopy. (4) Patients with an American Society of Anesthesiologists (ASA) physical status classification of 4 or higher. (5) Patients with severe coagulopathy or severe thrombocytopenia, defined as: - INR = 2.0 - Platelet count = 20,000/µL (6) Patients with acute or chronic severe medical, neurologic, or psychiatric conditions that, in the opinion of the principal investigator, may pose a risk to participant safety, interfere with compliance with the study schedule, or compromise the achievement of the study objectives. (7) Patients with a life expectancy of less than 2 years. (8) Women who are pregnant or have the potential to become pregnant. (9) Patients who are considered unable to comply with the requirements of this clinical trial or to cooperate adequately with the investigator. (10) Lesions located at any of the following sites: - Appendiceal orifice - Ileocecal valve - Intradiverticular location (11) Pedunculated or semipedunculated polyps, classified as Paris classification Ip or Isp. (12) Lesions histologically diagnosed as traditional serrated adenoma (TSA). (13) Lesions with high-grade dysplasia confirmed by histopathologic examination. (14) Lesions diagnosed as colorectal cancer by histopathologic examination. (15) Lesions requiring surgery because complete resection is not feasible using standard endoscopic techniques. (16) Lesions incompletely resected during the index procedure, defined as endoscopically visible residual lesion at the end of the procedure. (17) Lesions removed by endoscopic submucosal dissection (ESD). (18) Lesions removed by a full-thickness resection device (FTRD). (19) Lesions removed by en bloc resection. (20) Cases in which delayed perforation occurred during the procedure and surgical treatment was performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-Inferiority of 12-Month vs. 6-Month Surveillance: Comparison of Local Recurrence Rates at First Surveillance Endoscopy after Standardized pEMR and STSC. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the size, histologic classification, and proportion of invasive features, including high-grade dysplasia or cancer, in recurrent lesions between the two groups.;To compare the incidence of advanced recurrence, defined as recurrence with high-grade dysplasia or cancer, between the two groups.;To compare the retreatment methods for recurrent lesions, including standard polypectomy, endoscopic submucosal dissection, or surgery, and the clinical difficulty of retreatment between the two groups.;To compare the incidence of adverse events related to surveillance colonoscopy and retreatment between the two groups.;To compare the surveillance colonoscopy adherence rate and the deviation from the planned surveillance time between the two groups. | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Young Kim
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed