💬In plain words
What the trial is, and whether it could suit you
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.
The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such a
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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