Early Pancreatic Stent Placement for Preventing PEP

NCT06250803 | Recruiting FDA Device

• 1 other identifier: PJ 2023-14-12
• Study Type: interventional
• Target: 768
• Locations: 1 country
• Sites: 2

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).

Conditions

Cholangiopancreatography, Endoscopic Rretrograde; Post-ERCP Pancreatitis

Keywords

Cholangiopancreatography, Endoscopic Rretrograde; pancreatic stent; post-ERCP pancreatitis

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of post-ERCP pancreatitis

  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.

  up to 1 months

Secondary Outcomes (3)

• the incidence of hyperamylasemia

  up to 1 months

• the rate of stenting success

  Intra-procedure

• the incidence of other ERCP-related adverse events

  within 30 days after ERCP

Study Arms (2)

early pancreatic stent placement (EPSP)

EXPERIMENTAL

a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)

Device: early pancreatic stent placement (EPSP)

late pancreatic stent placement (LPSP)

OTHER

a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage

Device: early pancreatic stent placement (EPSP)

Interventions

early pancreatic stent placement (EPSP) DEVICE

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.

Also known as: late pancreatic stent placement (EPSP)

early pancreatic stent placement (EPSP); late pancreatic stent placement (LPSP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Anqing Municipal Hospital: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator
• Tongcheng People's Hospital of Anhui province: collaborator
• Fuyang people's hospital: collaborator

Study Sites (2)

Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

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Central Study Contacts

Qiao Mei, MD

CONTACT

8613865977696; meiqiaomq@aliyun.com

Junjun Bao, MD

CONTACT

8613655697005; csbj01@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For enhanced objectivity in data analysis, the project statisticians will be blinded to the arm allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)