Large benign tumor or precancerous lesion in duodenal ampulla
Conditions
Interventions
intervention group:endoscopic radiofrequency ablation in the treatment of large benign tumors or precancerous lesions in the duodenal ampulla
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Patients =18 years old and younger than 90 years old. (2) Patients with large benign tumors (>2cm) or precancerous lesions (high-grade intraepithelial neoplasia as detected by papillary biopsy or ERCP biliary and pancreatic duct brush) in the ampulla of the duodenum. (3) EUS+ epigastric enhanced MRCP or CT indicated ampulla occupying lesions, which were confined to the duodenal proper base and did not involve pancreatic parenchyma. (4) The subjects and their family members (guardians) agree to participate in this study, fully understand the benefits and risks of this study, are willing to participate, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Adenocarcinoma was found in duodenal ampulla biopsy or biliary pancreatic duct brush examination; (2) Patients with coagulation disorders or platelets < 50*10^9/L; (3) EUS/ epigastric enhanced MRCP/ enhanced CT suggested involvement of serosa and pancreatic parenchyma or malignant metastasis; (4) Patients with severe respiratory, cardiovascular, cerebrovascular, blood system and other primary diseases; (5) seriously ill with mental illness or infectious diseases; (6) under 18 years of age or over 90 years of age; (7) Abdominal infection, abscess or a lot of ascites; (8) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor residual rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding;Perforation rate;postoperative infection rate;postoperative pancreatitis rate;Postoperative bile duct stenosis rate; | — |
Countries
China
Contacts
Public ContactBaiwen Li
Shanghai General Hospital
Outcome results
None listed