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

Study Overview
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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.

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.

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

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Device: Endoscopic Biliary Stenting
* Procedure: Surgical treatment Bilio-enteric anastomosis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic Biliary Stenting<br>Temporary self-expandable metallic covered stent | Device: Endoscopic Biliary Stenting<br>* Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months<br>|
| Active Comparator: Surgical treatment<br>Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation | Procedure: Surgical treatment Bilio-enteric anastomosis<br>* Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalization of serum alkaline phosphatase (considered as < 130 UI/L) | A normal value of serum alkaline phosphatase will be considered as < 130 UI/L | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (EORTC health surveys) | EORTC health surveys will administered to assess quality of life. | At 18 months | 
| abdominal pain (Clinical symptoms assessed by Izbicki's score) | Clinical symptoms assessed by Izbicki's score, | at 1, 3, 6, 12,18 months after the procedure | 
| jaundice, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure | 
| pruritus, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure | 
| pale stool, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure | 
| dark urine. (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure | 
| Cholestasis | Biological measures Cholestasis Bilirubinemia < 1,2 mg/dl (norms : 0,1 à 1,2 mg / dl) Gamma GT < 50 UI / L | At 1, 3, 6, 12, 18 months after the procedure | 
| Cytolysis | Biological measures Cytolysis TGO < 40 UI / L (norms : 15 à 40 UI / L) TGP < 40 UI / L (norms : 10 à 40 UI / L) | At 1, 3, 6, 12, 18 months after the procedure | 
| Liver failure | Biological measures Liver failure TP > 60% (norms : 60 à 120%) Facteur V > 60% (norms : 60 à 120%) | At 1, 3, 6, 12, 18 months after the procedure | 
| CT-Scan (Morphological assessment) | Morphological assessment by CT-Scan, Pseudocyst, main pancreatic duct > 3 mm, inflammatory cephalic mass > 4 cm, biliary duct stricture, pancreatic calcifications | At 6 and 18 months after the procedure | 
| Bili-MRI | Morphological assessment by Bili-MRI, Pseudocyst, main pancreatic duct > 3 mm, inflammatory cephalic mass > 4 cm, biliary duct stricture, pancreatic calcifications | At 6 and 18 months after the procedure | 
| presence of surgical complications ( dindo and Clavien ) |  | At 1, 3, 6, 12, 18 months | 
| Hospital length of stay |  | At 1, 3, 6, 12, 18 months | 
| number of re - hospitalization |  | At 1, 3, 6, 12, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pancreatitis, Clinical Trial, Bile stricture, Endoscopy, Surgery