NCT02366988

The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis

Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures. The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis. The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.

Detailed description

This study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DEVICE	Endoscopic Biliary Stenting	Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months
PROCEDURE	Surgical treatment Bilio-enteric anastomosis	Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-02-20
• Last updated: 2018-06-21

Locations

7 sites across 1 country: France