NCT02366988

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

3.3 years

First QC Date

September 24, 2014

Last Update Submit

June 19, 2018

Conditions

Chronic Pancreatitis

Keywords

Chronic pancreatitisClinical TrialBile strictureEndoscopySurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Quality of Life (EORTC health surveys)

    At 18 months

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

    at 1, 3, 6, 12,18 months after the procedure

  • jaundice, (Clinical symptoms assessed)

    at 1, 3, 6, 12,18 months after the procedure

  • pruritus, (Clinical symptoms assessed)

    at 1, 3, 6, 12,18 months after the procedure

  • pale stool, (Clinical symptoms assessed)

    at 1, 3, 6, 12,18 months after the procedure

  • +9 more secondary outcomes

Study Arms (2)

Endoscopic Biliary Stenting

ACTIVE COMPARATOR

Temporary self-expandable metallic covered stent

Device: Endoscopic Biliary Stenting

Surgical treatment

ACTIVE COMPARATOR

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

Procedure: Surgical treatment Bilio-enteric anastomosis

Interventions

Endoscopic Biliary StentingDEVICE

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

Endoscopic Biliary Stenting
Surgical treatment Bilio-enteric anastomosisPROCEDURE

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

Surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre hospitalier

Béthune, France

Location

Centre hospitalier

Dunkirk, France

Location

Centre Hospitalier Dr Schaffner

Lens, France

Location

Clinique de la Louvière

Lille, France

Location

Hôpital St Philibert

Lomme, France

Location

Centre hospitalier

Roubaix, France

Location

Centre hospitalier

Valencienne, France

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe ZERBIB, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

February 20, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Locations

FR(7)