Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Tract Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pancreatic duct stenting with plastic stent

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Pancreatic duct stenting with plastic stent

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No