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

University Hospital, Lille7 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pancreatitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Centre hospitalier

Béthune, France

Centre hospitalier

Dunkirk, France

Centre Hospitalier Dr Schaffner

Lens, France

Clinique de la Louvière

Lille, France

Hôpital St Philibert

Lomme, France

Centre hospitalier

Roubaix, France

Centre hospitalier

Valencienne, France

Outcomes

Primary Outcomes

normalization of serum alkaline phosphatase (considered as < 130 UI/L)

A normal value of serum alkaline phosphatase will be considered as \< 130 UI/L

Time frame: 18 months

Secondary Outcomes

Quality of Life (EORTC health surveys)

EORTC health surveys will administered to assess quality of life.

Time frame: At 18 months

abdominal pain (Clinical symptoms assessed by Izbicki's score)

Clinical symptoms assessed by Izbicki's score,