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Optimal Placement Duration of Pancreatic Duct Stent

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691674
Enrollment
122
Registered
2020-12-31
Start date
2021-02-01
Completion date
2024-08-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Post-ERCP Acute Pancreatitis, Stent Dislodgement

Brief summary

A randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (PDS) inserted during ERCP: 2 vs 4 weeks

Detailed description

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.

Interventions

PROCEDUREEndoscopy

Endoscopic removal of the pancreatic stent

Sponsors

Seoul National University Hospital
CollaboratorOTHER
Gachon University Gil Medical Center
CollaboratorOTHER
Gyeongsang National University Hospital
CollaboratorOTHER
Kyungpook National University Hospital
CollaboratorOTHER
Severance Hospital
CollaboratorOTHER
The Catholic University of Korea
CollaboratorOTHER
Korea University Ansan Hospital
CollaboratorOTHER
Pusan National University Hospital
CollaboratorOTHER
DongGuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who underwent the pancreatic duct stent placement during ERCP

Exclusion criteria

* Patients who had pancreatic duct stent for the purpose of pancreatic interventions * Patients who underwent simultaneous bile duct stenting

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with undergoing endoscopic procedures2 weeks (control group) or 4 weeks (study group) following ERCPThe necessity of endoscopic procedure for pancreatic duct stent removal

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026