Clinical trial NCT05307861: Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention
Official title: Plastic vs Biodegradable Pancreatic Stent Comparison in the Prevention of Post-ERCP Pancreatitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Tract Diseases
Keywords: Biliary tract diseases
pancreatic duct
stents
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PEP prevention at 72 hours
timeFrame: up to 72 hours after randomization
Secondary outcomes:
measure: PEP prevention at 4 weeks
timeFrame: up to 4 weeks after randomization
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Carlos Robles-Medranda
state: Guayas
Study officials:
affiliation: Ecuadorian Institute of Digestive Diseases
name: Carlos Robles-Medranda
role: PRINCIPAL_INVESTIGATOR
References:
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