Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01671-44 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
sponsor decision: not enough inclusion
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Biliary Stenting | Active Comparator | Temporary self-expandable metallic covered stent |
|
| Surgical treatment | Active Comparator | Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Biliary Stenting | Device | Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EORTC health surveys) | EORTC health surveys will administered to assess quality of life. | At 18 months |
| abdominal pain (Clinical symptoms assessed by Izbicki's score) | Clinical symptoms assessed by Izbicki's score, |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe ZERBIB, MD, PhD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier | Béthune | France | ||||
| Centre hospitalier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgical treatment Bilio-enteric anastomosis | Procedure | Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation |
|
| at 1, 3, 6, 12,18 months after the procedure |
| jaundice, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure |
| pruritus, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure |
| pale stool, (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure |
| dark urine. (Clinical symptoms assessed) | Clinical symptoms assessed | at 1, 3, 6, 12,18 months after the procedure |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Dunkirk |
| 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 |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided