Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

NCT05307861 | Unknown DMC FDA Device

• 1 other identifier: IECED-14022022
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple risk factors have been linked with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP); therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention. The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.

Conditions

Biliary Tract Diseases

Keywords

Biliary tract diseases; pancreatic duct; stents

Outcome Measures

Primary Outcomes (1)

• PEP prevention at 72 hours

  Determine if plastic or biodegradable pancreatic stent placement renders PEP prevention. PEP is defined as proposed by Cotton et al in 1991(new hospitalization admission or 2/3-day hospital stay extension due to an abdominal pain suggestive of pancreatitis, plus a threefold increase of serum amylase/lipase above the normal limits 24 hours post-procedure).

  up to 72 hours after randomization

Secondary Outcomes (1)

• PEP prevention at 4 weeks

  up to 4 weeks after randomization

Study Arms (2)

Pancreatic duct stenting with plastic stent

ACTIVE COMPARATOR

Plastic pancreatic duct stent placement (5fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.

Device: Pancreatic duct stenting with plastic stent; Device: Pancreatic duct stenting with Biodegradable Stent

Pancreatic duct stenting with Biodegradable Stent

ACTIVE COMPARATOR

Biodegradable pancreatic duct stent placement (6fr x 4 cm or 6fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.

Device: Pancreatic duct stenting with plastic stent; Device: Pancreatic duct stenting with Biodegradable Stent

Interventions

Pancreatic duct stenting with plastic stent DEVICE

Plastic pancreatic duct stent placement (5fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.

Pancreatic duct stenting with Biodegradable Stent; Pancreatic duct stenting with plastic stent

Pancreatic duct stenting with Biodegradable Stent DEVICE

Biodegradable pancreatic duct stent placement (6fr x 4 cm or 6fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.

Pancreatic duct stenting with Biodegradable Stent; Pancreatic duct stenting with plastic stent

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is scheduled for ERCP
• Patient is 18 years old or older
• Biliary tract disease presence
• Non-manipulated pancreatic papilla
• Written informed consent provided

You may not qualify if:

• Patient not requiring pancreatic stenting during ERCP
• Failed pancreatic stent placement
• Patients at risk of fluid overload
• Patients with cholangitis, sepsis, acute/flared up chronic pancreatitis
• Recent previous biliary tract manipulation (i.e., pancreatoscopy, wirsungoscopy, etc.)
• Hemodynamic instability
• Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV)
• Pregnancy or nursing
• Refuse to participate in the study or to sign corresponding informed consent

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Carlos Robles-Medranda

Guayaquil, Guayas, 090505, Ecuador

Location

Related 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 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

• Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.

  PMID: 25088919 RESULT

• Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

  PMID: 15173799 RESULT

• Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 RESULT

• Moffatt DC, Yu BN, Yie W, Bernstein CN. Trends in utilization of diagnostic and therapeutic ERCP and cholecystectomy over the past 25 years: a population-based study. Gastrointest Endosc. 2014 Apr;79(4):615-22. doi: 10.1016/j.gie.2013.08.028. Epub 2013 Oct 8.

  PMID: 24119510 RESULT

• 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

• Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.

  PMID: 23920031 RESULT

• Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.

  PMID: 32145287 RESULT

• Phillip V, Pukitis A, Epstein A, Hapfelmeier A, Haf D, Schwab M, Demir IE, Rosendahl J, Hoffmeister A, Schmid RM, Weber A, Algul H. Pancreatic stenting to prevent post-ERCP pancreatitis: a randomized multicenter trial. Endosc Int Open. 2019 Jul;7(7):E860-E868. doi: 10.1055/a-0886-6384. Epub 2019 Jul 3.

  PMID: 31281872 RESULT

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Carlos Robles-Medranda

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: February 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)