Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364397
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-03
Brief Title:
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPRIT
Brief Summary:
The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography ERCP works to treat idiopathic recurrent pancreatitis IRAP in adults It also clarify the efficacy of ERCP in the diagnosis of IRAP The main questions it aims to answer are
Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients Does ERCP contribute to identify the etiology of IRAP patients
Participants will be randomly allocated to receive ERCP pancreatic sphincterotomy and pancreatic stent placement or conservative treatment and be followed for 1 year
Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients Does ERCP contribute to identify the etiology of IRAP patients
Participants will be randomly allocated to receive ERCP pancreatic sphincterotomy and pancreatic stent placement or conservative treatment and be followed for 1 year
Detailed Description:
Recurrent acute pancreatitis RAP is defined as 2 or more distinct episodes of acute pancreatitis AP with complete resolution between each episode and absence of irreversible structural and functional changes in pancreas RAP has an estimated annual incidence of 8-10 per 100000 and the recurrence rate is as high as 10-30 in AP patients At present biliary alcoholic and hypertriglyceridemia are common causes of RAP There are also a variety of causes that may contribute to recurrent episodes of AP such as gene mutations pancreas divisum ampullary neoplasms and sphincter of Oddi dysfunction About 80 of RAP patients can be identified through routine clinical investigations include proper history physical examination imaging examination however the etiology in up to 20 of cases still not be clarified and these patients is called idiopathic recurrent acute pancreatitis IRAP
Endoscopic retrograde cholangiopancreatography ERCP is an important minimally invasive treatment for pancreatic diseases However the role of ERCP in IRAP patients with normal biliary and pancreatic anatomy remains controversial and there is a lack of high-quality clinical research evidence on endoscopic treatment of IRAP In a small sample size N34 open-label randomized controlled study IRAP patients were assigned to the experimental group with pancreatic duct stent placement and the control group with selective pancreatograms but no stent This study demonstrated that stent placement was able to reduce the recurrence rate of AP 53 vs 11 P 002 Coté et al performed an open-label randomized trial N89 of ERCP with sphincter of Oddi manometry for IRAP patients Among patients with pancreatic sphincter dysfunction they found that biliary sphincterotomy and combination of biliary and pancreatic sphincterotomy have similar effects in preventing recurrence of AP and there was also no significant difference between biliary sphincterotomy and sham surgery in patients with normal sphincter of Oddi manometry However some retrospective studies had shown that sphincterotomy works to reduce the recurrence rate of acute pancreatitis
Currently there is a shortage of high-quality evidence and the wide variation in different study designs has led to controversial conclusions Given the long-standing controversy we propose to conduct a randomized controlled trial to investigate the efficacy of ERCP in the diagnosis and treatment of Idiopathic recurrent acute pancreatitis
Endoscopic retrograde cholangiopancreatography ERCP is an important minimally invasive treatment for pancreatic diseases However the role of ERCP in IRAP patients with normal biliary and pancreatic anatomy remains controversial and there is a lack of high-quality clinical research evidence on endoscopic treatment of IRAP In a small sample size N34 open-label randomized controlled study IRAP patients were assigned to the experimental group with pancreatic duct stent placement and the control group with selective pancreatograms but no stent This study demonstrated that stent placement was able to reduce the recurrence rate of AP 53 vs 11 P 002 Coté et al performed an open-label randomized trial N89 of ERCP with sphincter of Oddi manometry for IRAP patients Among patients with pancreatic sphincter dysfunction they found that biliary sphincterotomy and combination of biliary and pancreatic sphincterotomy have similar effects in preventing recurrence of AP and there was also no significant difference between biliary sphincterotomy and sham surgery in patients with normal sphincter of Oddi manometry However some retrospective studies had shown that sphincterotomy works to reduce the recurrence rate of acute pancreatitis
Currently there is a shortage of high-quality evidence and the wide variation in different study designs has led to controversial conclusions Given the long-standing controversy we propose to conduct a randomized controlled trial to investigate the efficacy of ERCP in the diagnosis and treatment of Idiopathic recurrent acute pancreatitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None