External drainage methods for pancreatic surgery complications
The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy: A Multi-center Prospective Randomized Controlled Phase Clinical Trial
This study is testing whether using external drainage methods after pancreatic surgery can help prevent complications like leaks and improve recovery for patients with pancreatic tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 322 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06322680 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of external drainage of the main pancreatic duct and common bile duct on the occurrence of postoperative pancreatic fistula following pancreaticoduodenectomy. The research aims to compare the effectiveness of external versus internal drainage methods in reducing complications such as pancreatic fistula, delayed gastric emptying, and biliary leakage. By enrolling patients who require pancreaticoduodenectomy due to tumors, the study will assess clinical outcomes and complications associated with each drainage approach. The findings could help refine surgical techniques and improve patient recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with tumors requiring pancreaticoduodenectomy and a good performance status.
Not a fit: Patients with serious dysfunction in blood, heart, lung, or autoimmune systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative complications, improving recovery and survival rates for patients undergoing pancreaticoduodenectomy.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of external drainage methods, indicating that this area of research is still evolving.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.