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Chronic PancreatitisPASTECNCT02366988

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

A study testing Endoscopic Biliary Stenting and Surgical treatment Bilio-enteric anastomosis in people with Chronic Pancreatitis, run by University Hospital, Lille at 7 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pancreatitis
What is being tested?
Endoscopic Biliary Stenting and Surgical treatment Bilio-enteric anastomosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
7 sitesFrance
Study dates
Feb 2015to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pancreatic malignancy
  • Cirrhosis
  • Portal vein thrombosis, portal cavernoma
  • Primary sclerosing cholangitis
  • Recent acute pancreatitis (i.e., in the previous 3 weeks)
  • Acute hepatitis
Show all 15Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Centre hospitalier

    Béthune

  • Centre hospitalier

    Dunkirk

  • Centre Hospitalier Dr Schaffner

    Lens

  • Clinique de la Louvière

    Lille

  • Hôpital St Philibert

    Lomme

  • Centre hospitalier

    Roubaix

  • Centre hospitalier

    Valencienne

Other trials in France

About this study

Official title: 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.

Read the detailed description

This study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period.

Being tested
Endoscopic Biliary Stenting, Surgical treatment Bilio-enteric anastomosis
Keywords
Chronic pancreatitis, Clinical Trial, Bile stricture, Endoscopy, Surgery
Medical subject headings
Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Biliary StentingDevice

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

  • Surgical treatment Bilio-enteric anastomosisProcedure or surgery

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

Study groups in NCT02366988
Study groupRoleWhat they receive
Endoscopic Biliary StentingActive comparatorTemporary self-expandable metallic covered stent
Receives: Device: Endoscopic Biliary Stenting
Surgical treatmentActive comparatorBilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation
Receives: Procedure: Surgical treatment Bilio-enteric anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months

Secondary outcomes (14)

  1. Quality of Life (EORTC health surveys)

    EORTC health surveys will administered to assess quality of life.

    Measured: At 18 months

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

    Clinical symptoms assessed by Izbicki's score,

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

  3. jaundice, (Clinical symptoms assessed)

    Clinical symptoms assessed

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

  4. pruritus, (Clinical symptoms assessed)

    Clinical symptoms assessed

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

  5. pale stool, (Clinical symptoms assessed)

    Clinical symptoms assessed

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

  6. dark urine. (Clinical symptoms assessed)

    Clinical symptoms assessed

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

  7. Cholestasis

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

    Measured: At 1, 3, 6, 12, 18 months after the procedure

  8. Cytolysis

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

    Measured: At 1, 3, 6, 12, 18 months after the procedure

  9. Liver failure

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

    Measured: At 1, 3, 6, 12, 18 months after the procedure

  10. 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

    Measured: At 6 and 18 months after the procedure

  11. Bili-MRI

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

    Measured: At 6 and 18 months after the procedure

  12. presence of surgical complications ( dindo and Clavien )

    Measured: At 1, 3, 6, 12, 18 months

  13. Hospital length of stay

    Measured: At 1, 3, 6, 12, 18 months

  14. number of re - hospitalization

    Measured: At 1, 3, 6, 12, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2018
  4. Study completionJun 2018

Why it stopped: sponsor decision: not enough inclusion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366988
Sponsor's protocol ID
2012_43
Other IDs
2013-A01671-44
Acronym
PASTEC
Status last verified
Jun 2018
First submitted
24 Sep 2014
Last updated
21 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Biliary Stenting and Surgical treatment Bilio-enteric anastomosis in people with Chronic Pancreatitis, run by University Hospital, Lille at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: sponsor decision: not enough inclusion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

normalization of serum alkaline phosphatase (considered as < 130 UI/L) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.

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