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Optimal Placement Duration of Pancreatic Duct Stent

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ClinicalTrials.gov Identifier: NCT04691674
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
Seoul National University Hospital
Gachon University Gil Medical Center
Gyeongsang National University Hospital
Kyungpook National University Hospital
Severance Hospital
The Catholic University of Korea
Korea University
Pusan National University Hospital
Information provided by (Responsible Party):
Dong Kee Jang, DongGuk University

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

Condition or disease Intervention/treatment Phase
Cholangitis Post-ERCP Acute Pancreatitis Stent Dislodgement Procedure: Endoscopy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Endoscopic removal of pancreatic duct stent at 4 weeks following ERCP, unless spontaneously dislodged.
 Procedure: Endoscopy
Endoscopic removal of the pancreatic stent
Placebo Comparator: Control group
Endoscopic removal of pancreatic duct stent at 2 weeks following ERCP, unless spontaneously dislodged.
 Procedure: Endoscopy
Endoscopic removal of the pancreatic stent


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691674


Contacts
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Contact: Dong Kee Jang, MD, PhD +82319617129 mapmotive@hanmail.net

Locations
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Korea, Republic of
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
Sponsors and Collaborators
DongGuk University
Seoul National University Hospital
Gachon University Gil Medical Center
Gyeongsang National University Hospital
Kyungpook National University Hospital
Severance Hospital
The Catholic University of Korea
Korea University
Pusan National University Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Dong Kee Jang, Principal investigator, DongGuk University
ClinicalTrials.gov Identifier: NCT04691674    
Other Study ID Numbers: 2020-10-024-003
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Cholangitis
Pancreatic Diseases
 Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases