Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different methods of draining the main pancreatic duct and the bile duct after a type of surgery called pancreaticoduodenectomy (PD) can affect complications that may occur afterward, particularly a condition known as postoperative pancreatic fistula (POPF). PD is a surgery often performed for tumors in specific areas of the pancreas and surrounding structures. While the surgery is common and safe, complications can still happen in a significant number of patients, which is why researchers want to explore ways to reduce these risks.

To participate in this study, individuals must be between 18 and 80 years old and have a good performance status, meaning they can carry out daily activities without major difficulties. They should be diagnosed with tumors in certain areas that require PD and must not have serious health issues that could complicate surgery. Participants can expect close monitoring during the study and will contribute to valuable research aimed at improving outcomes for future patients undergoing this type of surgery.

Gender

ALL

Eligibility 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.
• • With intermediate or high risk of postoperative pancreatic fistula (POPF) according to alternative fistula risk scoring system (A-FRS)
• 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.