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

Primary Purpose

Chronic Pancreatitis

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Endoscopic Biliary Stenting

Surgical treatment Bilio-enteric anastomosis

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Chronic pancreatitis, Clinical Trial, Bile stricture, Endoscopy, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre hospitalier
Centre hospitalier
Centre Hospitalier Dr Schaffner
Clinique de la Louvière
Hôpital St Philibert
Centre hospitalier
Centre hospitalier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endoscopic Biliary Stenting

Surgical treatment

Arm Description

Temporary self-expandable metallic covered stent

Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Quality of Life (EORTC health surveys)

EORTC health surveys will administered to assess quality of life.

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

Clinical symptoms assessed by Izbicki's score,

jaundice, (Clinical symptoms assessed)

Clinical symptoms assessed

pruritus, (Clinical symptoms assessed)

Clinical symptoms assessed

pale stool, (Clinical symptoms assessed)

Clinical symptoms assessed

dark urine. (Clinical symptoms assessed)

Clinical symptoms assessed

Cholestasis

Biological measures Cholestasis Bilirubinemia < 1,2 mg/dl (norms : 0,1 à 1,2 mg / dl) Gamma GT < 50 UI / L

Cytolysis

Biological measures Cytolysis TGO < 40 UI / L (norms : 15 à 40 UI / L) TGP < 40 UI / L (norms : 10 à 40 UI / L)

Liver failure

Biological measures Liver failure TP > 60% (norms : 60 à 120%) Facteur V > 60% (norms : 60 à 120%)

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

Bili-MRI

Morphological assessment by Bili-MRI, Pseudocyst, main pancreatic duct > 3 mm, inflammatory cephalic mass > 4 cm, biliary duct stricture, pancreatic calcifications

presence of surgical complications ( dindo and Clavien )

Hospital length of stay

number of re - hospitalization

Full Information

NCT ID

NCT02366988

First Posted

September 24, 2014

Last Updated

June 19, 2018

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT02366988

Brief Title

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

Acronym

PASTEC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

sponsor decision: not enough inclusion

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis

Keywords

Chronic pancreatitis, Clinical Trial, Bile stricture, Endoscopy, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic Biliary Stenting

Arm Type

Active Comparator

Arm Description

Temporary self-expandable metallic covered stent

Arm Title

Surgical treatment

Arm Type

Active Comparator

Arm Description

Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Intervention Type

Device

Intervention Name(s)

Endoscopic Biliary Stenting

Intervention Description

Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months

Intervention Type

Procedure

Intervention Name(s)

Surgical treatment Bilio-enteric anastomosis

Intervention Description

Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Quality of Life (EORTC health surveys)

Description

EORTC health surveys will administered to assess quality of life.

Time Frame

At 18 months

Title

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

Description

Clinical symptoms assessed by Izbicki's score,

Time Frame