A study of Preoperative Biliary Drainage RCT in patients with Pancreatic Carcinoma

Phase 4

• Conditions: Health Condition 1: null- Pancreatic Carcinoma Resectable

• Registration Number: CTRI/2015/01/005437
• Lead Sponsor: Boston Scientific

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age 18 or older

Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)

Biliary obstructive symptoms or signs

Bilirubin level at/above 100 μmol per liter (5.8 mg/dL)

Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy

Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum

Patients deemed as resectable by pancreatic protocol CT or MRI

Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion

Surgery intent within 4 weeks

Endoscopic and surgical treatment to be provided by same team

Exclusion Criteria

Biliary strictures caused by confirmed benign tumors

Biliary strictures caused by malignancies other than pancreatic, cancer, distal CBD cholangiocarcinoma and other periampullary cancers

Surgically altered biliary tract anatomy, not including prior cholecystectomy

Neoadjuvant chemotherapy for current malignancy

Palliative indication due to reasons other than surgical candidate status

Previous biliary drainage by ERCP/PTC

Patients for whom endoscopic techniques are contraindicated

Participation in another investigational trial within 90 days

Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of serious pre-operative, operative and post-operative adverse events to 120 days post randomization or to 30 days post-surgery, whichever comes lastTimepoint: 120 days