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

University Hospital, Lille

Status: Terminated

Conditions: Chronic Pancreatitis

Treatments: Procedure: Surgical treatment Bilio-enteric anastomosis; Device: Endoscopic Biliary Stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT02366988

2012_43

2013-A01671-44 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical symptomatic chronic pancreatitis-related biliary duct stricture (pain or jaundice or pale stool / dark urine)
• Biological symptomatic chronic pancreatitis-related biliary duct stricture (elevation of serum alkaline phosphatase (>2 or 3 times the upper limit of normal values) and/or of serum bilirubin for longer than 1 month)
• Isolated biliary stricture or biliary stricture associated to main pancreatic duct stricture
• Secondary biliary cirrhosis
• Progression of biliary stricture

Exclusion criteria

• Pancreatic malignancy
• Cirrhosis
• Portal vein thrombosis, portal cavernoma
• Primary sclerosing cholangitis
• Recent acute pancreatitis (i.e., in the previous 3 weeks)
• Acute hepatitis
• Post-surgical biliary stricture
• Biliary stones or pseudocyst-related biliary duct stricture
• Previous pancreatic surgery or endoscopic sphincterotomy
• Score IV or V on the American Society of Anesthesiologists scale
• Pregnancy or breastfeeding
• Patient aged under 18 yrs
• Emergency clinical situations (i.e., angiocholitis with septicemia)
• Non-compliant patients or suffering from legal incapacity
• Contra-indication for endoscopic or surgical treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Endoscopic Biliary Stenting

Active Comparator group

Description:

Temporary self-expandable metallic covered stent

Treatment:

Device: Endoscopic Biliary Stenting

Surgical treatment

Active Comparator group

Description:

Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Treatment:

Procedure: Surgical treatment Bilio-enteric anastomosis