Status:
UNKNOWN
Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Delayed Gastric Emptying and Nutrition
Lead Sponsor:
Asan Medical Center
Conditions:
Pancreaticoduodenectomy
Delayed Gastric Emptying
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure....
Detailed Description
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure....
Eligibility Criteria
Inclusion
- Age: 18 to 79 years
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- The preoperative examination showed that the lesion could invade to major artery.
- No distant metastasis
- Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
- Liver function : aspartate transaminase (AST)/alanine transaminase(ALT) less than 3 times upper limit of normal
- Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
- Patients who consented to and signed the consent
Exclusion
- Patients diagnosed with duodenal cancer
- Those with active or uncontrolled infections
- Those with severe psychiatric / neurological disorders
- Alcohol or other drug addicts
- Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy)
- 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 (ex. 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 pancreaticoduodenectomy, patients who require resection of other major abdominal organs, such as gastrectomy, colectomy
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2025
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT05314244
Start Date
May 1 2022
End Date
April 28 2025
Last Update
April 6 2022
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