Optimal Placement Duration of Pancreatic Duct Stent

NCT04691674 | Completed

• 1 other identifier: 2020-10-024-003
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholangitis; Post-ERCP Acute Pancreatitis; Stent Dislodgement

Outcome Measures

Primary Outcomes (1)

• Number of participants with undergoing endoscopic procedures

  The necessity of endoscopic procedure for pancreatic duct stent removal

  2 weeks (control group) or 4 weeks (study group) following ERCP

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Endoscopy

Control group

PLACEBO COMPARATOR

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

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

Endoscopic removal of the pancreatic stent

Control group; Study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent the pancreatic duct stent placement during ERCP

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Dongguk University Ilsan Hospital

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

Location

Related Publications (9)

• 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.

  PMID: 23612857 RESULT

• 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.

  PMID: 21295641 RESULT

• 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.

  PMID: 27546389 RESULT

• 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.

  PMID: 31863440 RESULT

• 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.

  PMID: 16185975 RESULT

• 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.

  PMID: 15933689 RESULT

• 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.

  PMID: 7988829 RESULT

• 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.

  PMID: 15067627 RESULT

• 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.

  PMID: 30502123 RESULT

MeSH Terms

Conditions

Cholangitis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: February 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)