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New treatment option for Pancreaticoduodenectomy
Official title Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy
ClinicalTrials.gov ID: NCT06322680
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- No serious dysfunction in blood system, heart, lung function, or autoimmune system (refer to the respective diagnostic criteria)
You likely can't join if
- Cancer in late stage including distant organ metastasis (liver, lung, peritoneum), metastasis to the hilar bile duct and hepatic duct, extensive...
- 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.
See the full eligibility 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...
- 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...
- 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)
- 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...
- 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...
- Poor Compliance: Poor compliance, unable or unwilling to sign informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.