Completed

Optimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks

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What is being tested

Endoscopy

Procedure
Who is being recruted

Bile Duct Diseases+1

+ Biliary Tract Diseases

+ Cholangitis

Over 20 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorDongGuk University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2021

Actual date on which the first participant was enrolled.

Endoscopic pancreatic duct stenting has been increasingly used for the treatment of a variety of pancreatic disorders including chronic pancreatitis, pancreatic duct stricture, drainage of pseudocysts, and the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). Several randomized, controlled trials and meta-analyses have proven a significant reduction in incidence and severity of post-ERCP pancreatitis (PEP) with prophylactic pancreatic duct stenting. The US and European guidelines recommend that pancreatic duct stents (PDS) be placed between 7-10 days and 5-10 days, respectively, in order to prevent PEP in some situations. Therefore, the placement of PDS has been an established essential procedure for preventing a fatal complication, PEP. Furthermore, PDS placement can facilitate difficult common bile duct cannulation. It may help not only to straighten papillary anatomy but also to identify the location of the biliary orifice. However, PDS tends to become occluded easily due to protein content, calcium carbonate crystals, and bacteria in the pancreatic juice. The occluded PDS can cause acute pancreatitis or abdominal pain. For this reason, the guidelines recommend PDS be placed within 10 days. Because of this policy, the patient must take the inconvenience of undergoing another endoscopic procedure to remove the PDS. However, all patients with occluded PDS do not have symptoms such as pain. In one series, only 6 percent of patients with clogged PDS developed symptoms. The low incidence of symptoms despite a high rate of stent occlusion suggests that the stent may function as a wick around which pancreatic juices continue to drain. In addition, the rate of spontaneous stent dislodgement was relatively high (65-86%) within 30 days according to a previous study. A recent study also reported that prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Taken together, PDS placed during ERCP do not need to be removed until any symptom develops. In particular, if the investigators can observe PDS for about a month without removing them, the PDS are more likely to pass out spontaneously, which could reduce unnecessary procedures. However, to date, there have been few randomized controlled studies on the optimal placement duration of PDS inserted during ERCP.

Official TitleOptimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks
NCT04691674
Principal SponsorDongGuk University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bile Duct DiseasesBiliary Tract DiseasesCholangitisDigestive System Diseases

Criteria

1 inclusion criteria required to participate
Patients who underwent the pancreatic duct stent placement during ERCP

2 exclusion criteria prevent from participating
Patients who had pancreatic duct stent for the purpose of pancreatic interventions

Patients who underwent simultaneous bile duct stenting

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Endoscopic removal of pancreatic duct stent at 2 weeks following ERCP, unless spontaneously dislodged.

Group II

Experimental
Endoscopic removal of pancreatic duct stent at 4 weeks following ERCP, unless spontaneously dislodged.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dongguk University Ilsan Hospital

Goyang-si, South KoreaOpen Dongguk University Ilsan Hospital in Google Maps
CompletedOne Study Center