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Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

NCT05307861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-04-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda · Ecuadorian Institute of Digestive Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-12-30
Completion
2023-01-30
FDA Device
Yes

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307861 on ClinicalTrials.gov