Optimal Placement Duration of Pancreatic Duct Stent

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04691674
• Other study ID #: 2020-10-024-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Pancreatitis
• Post-ERCP Acute Pancreatitis
• Stent Dislodgement

Intervention

Procedure:
• Endoscopy
Endoscopic removal of the pancreatic stent

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do

Sponsors (9)

Lead Sponsor	Collaborator
DongGuk University	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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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 — View 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 — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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