Acute Pancreatitis
Conditions
Keywords
Post-ERCP pancreatitis, Genetic variation
Brief summary
Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.
Detailed description
This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration & purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.
Interventions
PROCEDUREERCP
Two expert endoscopists will perform ERCP. Patients will be sedated with midazolam(2-5mg) and pethidine(25-50mg) with careful monitoring. Duodenoscope (TJF-240 or TJF-260; Olympus Corp., Tokyo, Japan) will be used. Cholangiography or pancreatography will be gathered after selective bile duct or pancreatic duct cannulation. Therapy such as endoscopic sphincterotomy, stent insertion, and etc., will be done.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis
Exclusion criteria
* \<18 years old * current pancreatitis (\<72hrs before ERCP) * pregnant woman, breast-feeding woman * patient refusal * contraindication of ERCP * patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy * chronic pancreatitis * patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis) * patients who have pancreatic or distal bile duct cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP pancreatitis | 24 hours after ERCP | Clinical pancreatitis, amylase at least 3 x normal \>24h after ERCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hyperamylasemia without symptom | 24 hours after ERCP | amylase at least 3 x normal \> 24h after ERCP, no abdominal pain |
| Severe post-ERCP pancreatitis | 24 hours after ERCP | Pancreatitis requiring hospitalization \>10 days, intervention(percutaneous drainage or surgery), development of necrosis, or pseudocyst |
| Length of stay | 3mo | Duration of hospitalization |
| Mortality | 3mo | mortality |
Countries
South Korea
Outcome results
None listed