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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Chronic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Biliary Stenting

Temporary self-expandable metallic covered stent

Group Type ACTIVE_COMPARATOR

Endoscopic Biliary Stenting

Intervention Type DEVICE

Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months

Surgical treatment

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

Group Type ACTIVE_COMPARATOR

Surgical treatment Bilio-enteric anastomosis

Intervention Type PROCEDURE

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

Interventions

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Endoscopic Biliary Stenting

Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months

Intervention Type DEVICE

Surgical treatment Bilio-enteric anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No