Early Pancreatic Stent Placement for Preventing PEP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

768 Participants
are divided into 2 treatment groups
Group A: early pancreatic stent placement (EPSP)Experimental treatment 1 intervention
Group B: late pancreatic stent placement (LPSP)Other 1 intervention

Trial outcomes

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.

Time frame
up to 1 months

Secondary outcomes

1

the incidence of hyperamylasemia

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.

Time frame
up to 1 months
2

the rate of stenting success

Time frame
Intra-procedure
3

the incidence of other ERCP-related adverse events

During the 30-day follow-up period,we will record other ERCP-related AEs such as gastrointestinal bleeding, cholangitis, and gastrointestinal perforation etc.

Time frame
within 30 days after ERCP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Anhui Medical University

Lead sponsor

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