A Single-Center Prospective Randomized Controlled Trial Evaluating the Efficacy of Tip-in Underwater Endoscopic Mucosal Resection for Nonampullary Superficial Duodenal Epithelial Tumors Measuring 10-20 mm

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适应症

试验速览

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•Patients will be considered eligible if all of the following criteria are met.
•The lesion has been diagnosed as a superficial nonampullary duodenal epithelial tumor (SNADET) based on endoscopic and/or histological findings.
•The lesion has an endoscopically assessed maximum diameter of 10-20 mm.
•The depth of invasion is endoscopically assessed as being confined to the mucosa.
•The patient is 18 years of age or older at the time of enrollment.
•The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•The most recent laboratory test results obtained within 3 months prior to enrollment meet all of the following criteria.
•White blood cell count >= 2000/mm3 and <= 12000/mm
•Hemoglobin >= 8.0 g/dL.
•Platelet count >= 100000/mm
•Total bilirubin <= 2.0 mg/dL.
•Aspartate aminotransferase (AST) <= 150 U/L and alanine aminotransferase (ALT) <= 150 U/L.
•Serum creatinine <= 2.0 mg/dL.
•Written informed consent has been obtained from the patient prior to participation in the study.

•Patients will be excluded if any of the following criteria are met:
•Pedunculated lesions.
•Lesions involving the major duodenal papilla or the minor duodenal papilla.
•Residual or recurrent lesions.
•Multiple adenomas associated with familial adenomatous polyposis.
•Patients judged by the principal investigator or sub-investigators to be inappropriate for participation in the study.

发起方

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