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Completed

NCT Number: NCT04691674

Optimal Placement Duration of Pancreatic Duct Stent

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy

Procedure

Endoscopic removal of the pancreatic stent

Primary outcomes

  1. Number of participants with undergoing endoscopic procedures

    Time frame: 2 weeks (control group) or 4 weeks (study group) following ERCP

    The necessity of endoscopic procedure for pancreatic duct stent removal

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Collaborators

  • Gachon University Gil Medical Center
  • Gyeongsang National University Hospital
  • Korea University Ansan Hospital
  • Kyungpook National University Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • The Catholic University of Korea

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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