Clinical trial NCT06250803: Early Pancreatic Stent Placement for Preventing PEP
Official title: Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis: a Multicentre, Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Rretrograde
Post-ERCP Pancreatitis
Keywords: Cholangiopancreatography, Endoscopic Rretrograde
pancreatic stent
post-ERCP pancreatitis
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Bengbu Medical University
name: Anqing Municipal Hospital
name: First Affiliated Hospital of Wannan Medical College
name: Tongcheng People's Hospital of Anhui province
name: Fuyang people's hospital
First posted: 2024-02-09
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence and severity of post-ERCP pancreatitis
timeFrame: up to 1 months
Secondary outcomes:
measure: the incidence of hyperamylasemia
timeFrame: up to 1 months
measure: the rate of stenting success
timeFrame: Intra-procedure
measure: the incidence of other ERCP-related adverse events
timeFrame: within 30 days after ERCP
Other outcomes:
Locations:
city: Hefei
country: China
facility: Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
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