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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Device: Endoscopic Biliary Stenting; Procedure: Surgical treatment Bilio-enteric anastomosis

Detailed Description

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
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Béthune, France
    • Centre Hospitalier
  • Dunkerque, France
    • Centre Hospitalier
  • Lens, France
    • Centre Hospitalier Dr Schaffner
  • Lille, France
    • Clinique de la Louvière
  • Lomme, France
    • Hôpital St Philibert
  • Roubaix, France
    • Centre Hospitalier
  • Valencienne, France
    • Centre Hospitalier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Chair: Philippe ZERBIB, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (ESTIMATE): February 20, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Surgery; Endoscopy; Clinical Trial; Chronic pancreatitis; Bile stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Constriction, Pathologic; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 2012_43; 2013-A01671-44 (OTHER: ID-RCB number, ANSM)