Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

March 24, 2022 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

Plastic vs Biodegradable Pancreatic Stent Comparison in the Prevention of Post-ERCP Pancreatitis: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is a high-skilled endoscopic procedure, which is currently mainly used as a therapeutic mean for various pancreaticobiliary disorders. Its most common serious adverse event is PEP. Multiple risk factors have been linked with PEP (patient/procedure/operator-related). Therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality.

A recent metanalysis reported an overall incidence of PEP close to 10%, with an even higher incidence (14.7%) in high-risk patients. PEP's risk factors work synergically and have exhibited up to a 40% incidence rate in multifactorial patients. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention.

The prophylactic use of pancreatic duct stents (especially 5 Fr stents) has exhibited a statistically significant PEP severity and incidence reduction; particularly for high-risk patients, for those who have undergone inadvertent repeated pancreatic duct cannulation or those in whom it is difficult to perform biliary cannulation. Controversially, failed pancreatic duct placement has shown a 34.7% PEP incidence rate and is considered an independent risk factor for PEP. In the case of stent migration, stent-induced perforation may arise regardless of the type of stent used (plastic or metallic), but if no signs of peritonitis are displayed, the endoscopic approach may suffice for stent removal and tracks closure. Rarely the surgical approach is guaranteed for migrated stents in the presence of peritonitis or retroperitoneal fluid collection.

The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Carlos Robles-Medranda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pancreatic duct stenting with plastic stent
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
Plastic pancreatic duct stent placement (5fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.
Device: Pancreatic duct stenting with Biodegradable Stent
Biodegradable pancreatic duct stent placement (6fr x 4 cm or 6fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.
Active Comparator: Pancreatic duct stenting with Biodegradable Stent
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
Plastic pancreatic duct stent placement (5fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.
Device: Pancreatic duct stenting with Biodegradable Stent
Biodegradable pancreatic duct stent placement (6fr x 4 cm or 6fr x 4 cm) for patients in need of pancreatic duct stenting during ERCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEP prevention at 72 hours
Time Frame: up to 72 hours after randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEP prevention at 4 weeks
Time Frame: up to 4 weeks after randomization
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 4 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Investigators

  • Principal Investigator: Carlos Robles-Medranda, Ecuadorian Institute of Digestive Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-14022022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biliary Tract Diseases

Clinical Trials on Pancreatic duct stenting with plastic stent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe