Status:
COMPLETED
Comparison of Functional Recovery Between Laparoscopic and Open Pancreaticoduodenectomy
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Bundang Hospital
Severance Hospital
Conditions:
Functional Recovery
Laparoscopy
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
Laparoscopic surgery has not changed much in safety compared with open surgery through many existing studies, and has become a procedure to help patients' recovery. Recently, laparoscopic surgery has...
Detailed Description
* Pancreatoduodenectomy is a standard procedure for periampullary disease of the duodenum (pancreatic cancer, biliary pancreatic cancer, bile duct cancer, etc.) and is a very extensive and complicated...
Eligibility Criteria
Inclusion
- Age: 19 to 80 years
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- The preoperative examination showed that the lesion could not be invaded by major blood vessels.
- No distant metastasis
- Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
- Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
- Patients who consented to and signed the consent
Exclusion
- Severe obesity (BMI\> 30)
- Those with active or uncontrolled infections
- Those with severe psychiatric / neurological disorders
- Alcohol or other drug addicts
- Patients included in other clinical studies that may affect this study
- Patients who cannot follow the directions of the researcher
- Those with uncontrolled heart disease
- Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
- Pelvic tumor, benign tumor, malignant tumor in other organs
- Patients who received prior chemotherapy
- In addition to the planned PD patients who require resection of other major abdominal organs (such as gastrectomy, colonic resection and portal / upper mesenteric vascular resection, more than standard PD)
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT03870698
Start Date
May 9 2019
End Date
August 31 2022
Last Update
February 27 2023
Active Locations (1)
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1
Asan medical center
Seoul, South Korea, 05505