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

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ClinicalTrials.gov Identifier: NCT02366988
Recruitment Status : Terminated (sponsor decision: not enough inclusion)
First Posted : February 20, 2015
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Device: Endoscopic Biliary Stenting Procedure: Surgical treatment Bilio-enteric anastomosis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis
Study Start Date : February 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. normalization of serum alkaline phosphatase (considered as < 130 UI/L) [ Time Frame: 18 months ]
    A normal value of serum alkaline phosphatase will be considered as < 130 UI/L


Secondary Outcome Measures :
  1. Quality of Life (EORTC health surveys) [ Time Frame: At 18 months ]
    EORTC health surveys will administered to assess quality of life.

  2. abdominal pain (Clinical symptoms assessed by Izbicki's score) [ Time Frame: at 1, 3, 6, 12,18 months after the procedure ]
    Clinical symptoms assessed by Izbicki's score,

  3. jaundice, (Clinical symptoms assessed) [ Time Frame: at 1, 3, 6, 12,18 months after the procedure ]
    Clinical symptoms assessed

  4. pruritus, (Clinical symptoms assessed) [ Time Frame: at 1, 3, 6, 12,18 months after the procedure ]
    Clinical symptoms assessed

  5. pale stool, (Clinical symptoms assessed) [ Time Frame: at 1, 3, 6, 12,18 months after the procedure ]
    Clinical symptoms assessed

  6. dark urine. (Clinical symptoms assessed) [ Time Frame: at 1, 3, 6, 12,18 months after the procedure ]
    Clinical symptoms assessed

  7. Cholestasis [ Time Frame: 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

  8. Cytolysis [ Time Frame: 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)

  9. Liver failure [ Time Frame: 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%)

  10. CT-Scan (Morphological assessment) [ Time Frame: 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

  11. Bili-MRI [ Time Frame: 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

  12. presence of surgical complications ( dindo and Clavien ) [ Time Frame: At 1, 3, 6, 12, 18 months ]
  13. Hospital length of stay [ Time Frame: At 1, 3, 6, 12, 18 months ]
  14. number of re - hospitalization [ Time Frame: At 1, 3, 6, 12, 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366988


Locations
France
Centre hospitalier
Béthune, France
Centre hospitalier
Dunkerque, France
Centre Hospitalier Dr Schaffner
Lens, France
Clinique de la Louvière
Lille, France
Hôpital St Philibert
Lomme, France
Centre hospitalier
Roubaix, France
Centre hospitalier
Valencienne, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Chair: Philippe ZERBIB, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02366988     History of Changes
Other Study ID Numbers: 2012_43
2013-A01671-44 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Keywords provided by University Hospital, Lille:
Chronic pancreatitis
Clinical Trial
Bile stricture
Endoscopy
Surgery

Additional relevant MeSH terms:
Pancreatitis
Constriction, Pathologic
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pathological Conditions, Anatomical