Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial-
Conditions
Interventions
P-stent
non P-stent
Sponsors
Japan Pancreatic Stent-Study Group (JPS-SG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Risk factors were divided into two groups: a) patient-related factors and b) procedure-related factors. Patient-related factors included: 1) age < 60, female gender, 2) history of pancreatitis, and 3) suspected biliary sphincter of Oddi disorder (SOD). Procedure-related factors included: 1) pancreatography first, 2) pancreatography &#8805; 2 times, 3) endoscopic pancreatic sphincterotomy (EPST), 4) precut, 5) endoscopic papillary balloon dilation (EPBD), 6) common bile duct (C) -tissue sampling (biopsy, brush, cytology), 7) pancreatic duct (P) -tissue sampling (biopsy, brush, cytology), 8) non-endoscopic sphincterotomy (ES) + endoscopic biliary drainage (EBD), 9) non ES + endoscopic nasobiliary drainage (ENBD), 10) common bile duct intraductal ultrasonography (C-IDUS), 11) pancreatic duct-intraductal ultrasonography (P&#8211;IDUS), 12) difficulty of cannulation ( &#8805; 15 minutes), and 13) procedure time ( &#8805; 30 minutes ) (Figure 2).
Exclusion criteria
Exclusion criteria: The following cases were excluded: 1) cases who could not provide written informed consent, 2) cases deemed inappropriate for this trial (although there were none in the present study), 3) cases with a performance status of 4, 4) cases in which the duodenal papilla could not be accessed endoscopically, 5) cases requiring pancreatic duct drainage, 6) cases with a history of prior ERCP procedures, 7) cases of postgastrectomy, 8) cases requiring endoscopic papillectomy, 9) cases of pancreatic head cancer with main pancreatic duct occlusion, 10) cases of pancreas divisum (excluding such cases at the stage when diagnosed by ERCP, due to the difficulty of diagnosis before pre-ERCP), 11) cases of chronic pancreatitis, 12) cases of intraductal papillary mucinous neoplasms (IPMN), 13) cases of gallstone pancreatitis, 14) cases of pancreaticobiliary maljunction, and 15) cases in which the ERCP procedure was not completed within 1 hour from the transoral insertion of the scope.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoints were the frequency and severity of post-ERCP pancreatitis in patients with risk factors. We also evaluated hyperamylasemia, the success rate of stent placement, the duration before stent dislodgment, and complications in both groups. We also evaluated risk factors for post-ERCP pancreatitis. | — |
Countries
Japan
Outcome results
None listed