NIPH Clinical Trials Search

Randomized controlled trial of optimal biliary drainage for patients with pancreatic cancer undergoing neoadjuvant therapy with biliary obstruction

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Pancreatic cancer
Date of first enrollment	18/09/2025
Target sample size	330
Countries of recruitment
Study type	Interventional
Intervention(s)	Endoscopic transpapillary biliary drainage

Outcome(s)

Primary Outcome

Proportion of event-free survivors at 12 weeks (recurrent biliary obstruction, pancreatitis, cholecystitis, non stent related cholangitis, gastrointestinal bleeding, aspiration pneumonia, liver abscess, gastrointestinal perforation, or death).

Secondary Outcome

- Event incidence rate at 12 weeks - Proportion of event-free survivors and event incidence rate at 12 weeks in patients with resectable pancreatic cancer - Proportion of event-free survivors and event incidence rate at 24 weeks in patients with borderline resectable pancreatic cancer - Proportion of each component of the primary endpoint - Technical and clinical success rates - Reintervention success rate - Proportion of patients who underwent surgical resection - Total operative time - Intraoperative blood loss - Postoperative complication rate - Postoperative length of hospital stay - R0 resection rate - Lymphovascular invasion rate - Lymph node metastasis rate

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Age 18 years or more at the time of obtaining informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Findings on contrast-enhanced CT or contrast-enhanced MRI consistent with invasive pancreatic ductal adenocarcinoma. 4. Determined to have resectable (R) or borderline resectable (BR) pancreatic cancer based on abdominal contrast-enhanced CT or MRI, and scheduled to undergo neoadjuvant therapy. 5. Presence of distal biliary stricture on contrast-enhanced CT or MRI (defined as extrahepatic bile duct obstruction with the proximal end of the stricture located at least 2 cm distal to the hepatic hilum), for which biliary drainage is deemed necessary. 6. No prior biliary drainage for malignant biliary obstruction using plastic stent (PS), endoscopic nasobiliary drainage (ENBD), or self-expandable metal stent (SEMS). In addition, no prior percutaneous biliary drainage (percutaneous transhepatic biliary drainage (PTBD) or percutaneous transhepatic gallbladder drainage (PTGBD)) has been performed. (Prior procedures for benign diseases such as choledocholithiasis or cholelithiasis are permitted.) 7. Written informed consent for participation in the study obtained from the patient based on their free will. Neoadjuvant therapy, The treatment modality is not specified and may include radiotherapy.
Exclude criteria	1. Concomitant acute cholangitis corresponding to Grade III (severe) according to the Tokyo Guidelines 2018. 2. Presence of gastrointestinal obstruction symptoms. 3. Suspected pancreatobiliary malunion based on imaging findings from CT, MRI, abdominal ultrasonography (AUS), or endoscopic ultrasonography (EUS). 4. Reconstructed gastrointestinal tract other than Billroth I. 5. Difficulty in discontinuing or substituting antithrombotic therapy according to the "Guideline, Management of antithrombotic agents for endoscopic procedures." 6. Considered inappropriate for participation in this study at the discretion of the investigator.