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

Chronic Pancreatitis Clinical Trial

— PASTEC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02366988
• Other study ID #: 2012_43
• Secondary ID: 2013-A01671-44
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Constriction, Pathologic
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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

Procedure:
• Surgical treatment Bilio-enteric anastomosis
Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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