Chronic Pancreatitis
Conditions
Keywords
Chronic pancreatitis, Clinical Trial, Bile stricture, Endoscopy, Surgery
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.
Interventions
Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months
PROCEDURESurgical treatment Bilio-enteric anastomosis
Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| normalization of serum alkaline phosphatase (considered as < 130 UI/L) | 18 months | A normal value of serum alkaline phosphatase will be considered as \< 130 UI/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| jaundice, (Clinical symptoms assessed) | at 1, 3, 6, 12,18 months after the procedure | Clinical symptoms assessed |
| Quality of Life (EORTC health surveys) | At 18 months | EORTC health surveys will administered to assess quality of life. |
| pruritus, (Clinical symptoms assessed) | at 1, 3, 6, 12,18 months after the procedure | Clinical symptoms assessed |
| pale stool, (Clinical symptoms assessed) | at 1, 3, 6, 12,18 months after the procedure | Clinical symptoms assessed |
| dark urine. (Clinical symptoms assessed) | at 1, 3, 6, 12,18 months after the procedure | Clinical symptoms assessed |
| Cholestasis | 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 |
| abdominal pain (Clinical symptoms assessed by Izbicki's score) | at 1, 3, 6, 12,18 months after the procedure | Clinical symptoms assessed by Izbicki's score, |
| Liver failure | 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%) |
| CT-Scan (Morphological assessment) | 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 |
| Bili-MRI | 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 |
| presence of surgical complications ( dindo and Clavien ) | At 1, 3, 6, 12, 18 months | — |
| Hospital length of stay | At 1, 3, 6, 12, 18 months | — |
| number of re - hospitalization | At 1, 3, 6, 12, 18 months | — |
| Cytolysis | 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) |
Countries
France
Outcome results
None listed