Clinical trial NCT02366988: The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis
Official title: Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pancreatitis
Keywords: Chronic pancreatitis
Clinical Trial
Bile stricture
Endoscopy
Surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: normalization of serum alkaline phosphatase (considered as < 130 UI/L)
timeFrame: 18 months
Secondary outcomes:
measure: Quality of Life (EORTC health surveys)
timeFrame: At 18 months
measure: abdominal pain (Clinical symptoms assessed by Izbicki's score)
timeFrame: at 1, 3, 6, 12,18 months after the procedure
measure: jaundice, (Clinical symptoms assessed)
timeFrame: at 1, 3, 6, 12,18 months after the procedure
measure: pruritus, (Clinical symptoms assessed)
timeFrame: at 1, 3, 6, 12,18 months after the procedure
measure: pale stool, (Clinical symptoms assessed)
timeFrame: at 1, 3, 6, 12,18 months after the procedure
measure: dark urine. (Clinical symptoms assessed)
timeFrame: at 1, 3, 6, 12,18 months after the procedure
measure: Cholestasis
timeFrame: At 1, 3, 6, 12, 18 months after the procedure
measure: Cytolysis
timeFrame: At 1, 3, 6, 12, 18 months after the procedure
measure: Liver failure
timeFrame: At 1, 3, 6, 12, 18 months after the procedure
measure: CT-Scan (Morphological assessment)
timeFrame: At 6 and 18 months after the procedure
measure: Bili-MRI
timeFrame: At 6 and 18 months after the procedure
measure: presence of surgical complications ( dindo and Clavien )
timeFrame: At 1, 3, 6, 12, 18 months
measure: Hospital length of stay
timeFrame: At 1, 3, 6, 12, 18 months
measure: number of re - hospitalization
timeFrame: At 1, 3, 6, 12, 18 months
Other outcomes:
Locations:
city: Béthune
country: France
facility: Centre hospitalier
city: Dunkerque
country: France
facility: Centre hospitalier
city: Lens
country: France
facility: Centre Hospitalier Dr Schaffner
city: Lille
country: France
facility: Clinique de la Louvière
city: Lomme
country: France
facility: Hôpital St Philibert
city: Roubaix
country: France
facility: Centre hospitalier
city: Valencienne
country: France
facility: Centre hospitalier
Study officials:
affiliation: University Hospital, Lille
name: Philippe ZERBIB, MD, PhD
role: STUDY_CHAIR
References: