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

Not Applicable

Terminated

• Conditions: Chronic Pancreatitis
• Interventions: Procedure: Surgical treatment Bilio-enteric anastomosis; Device: Endoscopic Biliary Stenting

• Registration Number: NCT02366988
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2014-09-24
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Surgical treatment Bilio-enteric anastomosis	Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation
Endoscopic Biliary Stenting	Endoscopic Biliary Stenting	Temporary self-expandable metallic covered stent

Primary Outcome Measures

Name	Time	Method
normalization of serum alkaline phosphatase (considered as < 130 UI/L)	18 months	A normal value of serum alkaline phosphatase will be considered as \< 130 UI/L

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Hôpital St Philibert; 🇫🇷 Lomme, France

Clinique de la Louvière; 🇫🇷 Lille, France

Centre hospitalier; 🇫🇷 Valencienne, France

Centre Hospitalier Dr Schaffner; 🇫🇷 Lens, France