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Optimal Placement Duration of Pancreatic Duct Stent

Primary Purpose

Cholangitis, Post-ERCP Acute Pancreatitis, Stent Dislodgement

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopy
Sponsored by
DongGuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongguk University Ilsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with undergoing endoscopic procedures
The necessity of endoscopic procedure for pancreatic duct stent removal

Secondary Outcome Measures

Full Information

First Posted
December 28, 2020
Last Updated
January 3, 2021
Sponsor
DongGuk University
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
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1. Study Identification

Unique Protocol Identification Number
NCT04691674
Brief Title
Optimal Placement Duration of Pancreatic Duct Stent
Official Title
Optimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DongGuk University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis, Post-ERCP Acute Pancreatitis, Stent Dislodgement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Endoscopic removal of pancreatic duct stent at 4 weeks following ERCP, unless spontaneously dislodged.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Endoscopic removal of pancreatic duct stent at 2 weeks following ERCP, unless spontaneously dislodged.
Intervention Type
Procedure
Intervention Name(s)
Endoscopy
Intervention Description
Endoscopic removal of the pancreatic stent
Primary Outcome Measure Information:
Title
Number of participants with undergoing endoscopic procedures
Description
The necessity of endoscopic procedure for pancreatic duct stent removal
Time Frame
2 weeks (control group) or 4 weeks (study group) following ERCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Kee Jang, MD, PhD
Phone
+82319617129
Email
mapmotive@hanmail.net
Facility Information:
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23612857
Citation
Mazaki T, Mado K, Masuda H, Shiono M. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis. J Gastroenterol. 2014 Feb;49(2):343-55. doi: 10.1007/s00535-013-0806-1. Epub 2013 Apr 24.
Results Reference
result
PubMed Identifier
21295641
Citation
Choudhary A, Bechtold ML, Arif M, Szary NM, Puli SR, Othman MO, Pais WP, Antillon MR, Roy PK. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc. 2011 Feb;73(2):275-82. doi: 10.1016/j.gie.2010.10.039.
Results Reference
result
PubMed Identifier
27546389
Citation
ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.
Results Reference
result
PubMed Identifier
31863440
Citation
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
Results Reference
result
PubMed Identifier
16185975
Citation
Goldberg E, Titus M, Haluszka O, Darwin P. Pancreatic-duct stent placement facilitates difficult common bile duct cannulation. Gastrointest Endosc. 2005 Oct;62(4):592-6. doi: 10.1016/j.gie.2005.04.046.
Results Reference
result
PubMed Identifier
15933689
Citation
Deviere J. Why do pancreatic stents become occluded? Gastrointest Endosc. 2005 Jun;61(7):867-8. doi: 10.1016/s0016-5107(05)00548-1. No abstract available.
Results Reference
result
PubMed Identifier
7988829
Citation
Ikenberry SO, Sherman S, Hawes RH, Smith M, Lehman GA. The occlusion rate of pancreatic stents. Gastrointest Endosc. 1994 Sep-Oct;40(5):611-3. doi: 10.1016/s0016-5107(94)70264-0. No abstract available.
Results Reference
result
PubMed Identifier
15067627
Citation
Rashdan A, Fogel EL, McHenry L Jr, Sherman S, Temkit M, Lehman GA. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis. Clin Gastroenterol Hepatol. 2004 Apr;2(4):322-9. doi: 10.1016/s1542-3565(04)00062-x.
Results Reference
result
PubMed Identifier
30502123
Citation
Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
Results Reference
result

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Optimal Placement Duration of Pancreatic Duct Stent

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