Status:
ACTIVE_NOT_RECRUITING
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Lead Sponsor:
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Conditions:
Pancreatic Cancer
Bile Duct Cancer
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Detailed Description
Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postop...
Eligibility Criteria
Inclusion
- Age: 21-75 years
- Clinically/histologically established diagnosis of the cancer;
- Preoperative imaging assessment is resectable or borderline resectable
Exclusion
- Benign tumors of the head of pancreas;
- Distant metastasis;
- Conversion to laparotomy;
- Instrumental findings of the tumor process prevalence;
- General somatic status on the ASA III-V scale;
- Acute pancreatitis;
- Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)).
- Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04763642
Start Date
January 1 2020
End Date
January 1 2025
Last Update
June 24 2024
Active Locations (1)
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1
Ochapovsky Regional Clinical Hospital № 1
Krasnodar, Krasnodarskiy Kray, Russia, 350068