Patients who receive PD for various diseases in the research units.
Conditions
Interventions
Main pancreatic duct and biliary duct external drainage:Dual external drainage of the pancreas and gallbladder, with an internal drain-silicone drain tube from the abdominal wall out of the body, conn
Main pancreatic duct and biliary duct internal drainage:For internal pancreaticobiliary drainage, the pancreatic duct was closed with a simple full suture, 4-0 PDS plus continuous anastomosis, and the
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Signed informed content obtained prior to treatment • Age = 18 years and = 80 years • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy =12 weeks and ASA score =2. • Based on clinical symptoms, imaging examinations, tumor markers, and other auxiliary examinations, the clinical diagnosis includes but is not limited to tumors of the pancreatic head, ampulla of Vater, duodenum, and distal common bile duct, requiring pancreaticoduodenectomy. • No serious dysfunction in blood system, heart, lung function, or autoimmune system (refer to the respective diagnostic criteria) • White blood cell (WBC) = 3 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelets (PLT) = 100 × 109/L; Hemoglobin (Hgb) = 90 g/L • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) = 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) = ULN; Creatinine (CRE) = 1.5 × ULN • Prothrombin time (PT) and international normalized ratio (INR) = 1.5 × ULN • Able to comply with research visit plans and other protocol requirements.
Exclusion criteria
Exclusion criteria: Cancer in late stage including distant organ metastasis (liver, lung, peritoneum), metastasis to the hilar bile duct and hepatic duct, extensive metastasis to the hepatic portal lymph nodes, tumor invasion of the superior mesenteric artery, celiac trunk, inferior vena cava, or abdominal aorta. • Heart Failure: Congestive heart failure with New York Heart Association (NYHA) heart function classification of 3 or 4. • Uncontrolled Hypertension: • Renal Failure: Renal failure or insufficiency requiring hemodialysis or peritoneal dialysis. • Active Infection: Serious active clinical infection (> Grade 2, NCI-CTCAE version 4.0). • Pregnancy or Lactation: Pregnant or lactating women. • Major Surgery: Patients who have undergone major surgery within 4 weeks of starting the trial or have not recovered from the side effects of such surgery. • Other Malignancies: Combined with other malignant tumors (patients who have been cured 3 years ago can be included). • Upper Gastrointestinal Bleeding: Excluding patients with upper gastrointestinal bleeding within 4 weeks before surgery or with a clear tendency of gastrointestinal bleeding that cannot be corrected by active medical treatment. • Poor Compliance: Poor compliance, unable or unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical Complications;Clavien-Dindo classification;Long-term survival related to malignant tumors; | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed