Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

Study Overview
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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.

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.

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

Conditions
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Biliary Tract Diseases

Intervention / Treatment
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* Device: Pancreatic duct stenting with plastic stent
* Device: Pancreatic duct stenting with Biodegradable Stent


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEP prevention at 4 weeks | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary tract diseases, pancreatic duct, stents