Cholangiopancreatography, Endoscopic Rretrograde, Post-ERCP Pancreatitis
Conditions
Keywords
Cholangiopancreatography, Endoscopic Rretrograde, pancreatic stent, post-ERCP pancreatitis
Brief summary
Our aim is to compare early versus late pancreatic stent placement in preventing PEP among patients with naive papilla. The EVL trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in PEP prevention.All patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in EVL research. In total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (EPSP) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)) and (2) late pancreatic stent placement (LPSP) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).The primary outcome is the rate and severity of PEP. The secondary outcomes are hyperamylasemia, the rate of stenting success, and other ERCP-related adverse events (AEs).
Detailed description
Patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study. Recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures. After obtaining signed consent forms, participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped (with a 1:1 ratio) into EPSP and LPSP
Interventions
DEVICEearly pancreatic stent placement (EPSP)
In the EPSP group, a single pig-tail pancreatic stent (5Fr) will be inserted instantly after ERC or EST, and subsequent biliary procedures will proceed as planned. In contrast, in the LPSP group, while keeping the PD guidewire in place, a single pig-tail PD stent (5Fr) will be ultimately placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage.
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Anqing Municipal Hospital
First Affiliated Hospital of Wannan Medical College
Tongcheng People's Hospital of Anhui province
Fuyang people's hospital
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
For enhanced objectivity in data analysis, the project statisticians will be blinded to the arm allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ERCP with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent.
Exclusion criteria
Participants who meet any of the following criteria will be excluded: 1. unreachable main papillae; 2. surgically altered gastrointestinal anatomy; 3. concurrent acute pancreatitis; 4. biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute); 5. failed biliary cannulation; 6. severe active cardiopulmonary disease; 7. breastfeeding or pregnancy; 8. ampullary tumour.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of post-ERCP pancreatitis | up to 1 months | Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of hyperamylasemia | up to 1 months | Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ERCP levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion. |
| the rate of stenting success | Intra-procedure | — |
| the incidence of other ERCP-related adverse events | within 30 days after ERCP | During the 30-day follow-up period,we will record other ERCP-related AEs such as gastrointestinal bleeding, cholangitis, and gastrointestinal perforation etc. |
Countries
China
Contacts
Primary ContactQiao Mei, MD
Backup ContactJunjun Bao, MD
Outcome results
None listed