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Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

Primary Purpose

Pancreatitis

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Pancreatic Stent

Indomethacin

Isosorbide Dinitrate

Ringer's lactate

About this trial

This is an interventional prevention trial for Pancreatitis focused on measuring Endoscopic Retrograde Cholangiopancreatography, Pancreatic duct stenting, Post-ERCP pancreatitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients at high risk of post-ERCP Pancreatitis undergoing ERCP are eligible to enter the study. At least one major or two minor criteria must be present for the patient to be considered at high risk for PEP:

Major

Sphincter of Oddi dysfunction.
History of previous PEP.
Pancreatic injection.
Precut sphincterotomy.
Balloon sphincter dilation without sphincterotomy.
Pancreatic guidewire passages > 1.

Minor

Female patients aged<60 years.
Nondilated common bile duct (CBD).
Normal serum bilirubin (<2mg/dl).
Failure to clear bile duct stones.
Failed cannulation.
Difficult cannulation (Time to CBD cannulation more than 10 min or more than five attempts at cannulation).

Exclusion Criteria:

Age younger than 15 years.
History of sphincterotomy.
Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis).
Uncontrolled coagulopathy.
Tumor of ampulla of Vater.
Those undergoing routine biliary-stent exchange.
Acute pancreatitis at the time of ERCP.
Chronic pancreatitis.
Regular NSAID use during preceding week.
Unable to tolerate indomethacin (Creatinine level >1.4 mg/dL or active peptic ulcer disease).
Unable to tolerate nitrates (closed-angle glaucoma).
Unable to tolerate aggressive hydration (cardiac insufficiency: NYHA FC II or higher, renal insufficiency, electrolyte disturbances, clinical signs of fluid overload including peripheral or pulmonary edema, liver dysfunction with varix>F1, or respiratory insufficiency).
Patients requiring pancreatic duct drainage: to bridge dominant strictures, bypass obstructing pancreatic duct stones, drain pseudocysts, seal duct disruptions, pancreatic head cancer with main PD obstruction, IPMN or Pancreas divisum.
Known main pancreatic duct stricture toward the head of pancreas.
Pregnancy or breastfeeding.
Refusal to participate in the study.

Sites / Locations

Shariati hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Pharmacological Prevention

Pancreatic Stent

Arm Description

Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting

Pancreatic Stent PLUS Pharmacological Prevention

Outcomes

Primary Outcome Measures

Post-ERCP pancreatitis

Pancreatitis is defined as new or worsened abdominal pain and tenderness with amylase levels at least three times above the upper limit of normal at 24 hours after the procedure, requiring hospital admission or a prolongation of planned admission.

Secondary Outcome Measures

Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)

Mild acute pancreatitis (No organ failure, No local or systemic complications) Moderately severe acute pancreatitis (transient organ failure that resolves within 48 h and/or Local or systemic complications without persistent organ failure) Severe acute pancreatitis (Persistent organ failure >48 h)

Full Information

NCT ID

NCT02368795

First Posted

February 2, 2015

Last Updated

November 5, 2015

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02368795

Brief Title

Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

Official Title

Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pancreatitis is the most important complication of ERCP. The severity of this condition varies from mild to severe and can lead to prolonged hospitalization, surgical interventions, and even death. Several patient-related and procedure related factors have been identified that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods have been proposed to avoid pancreatitis in patients at higher risk of this complication. Several studies have shown that different drug therapies (indomethacin suppository, a sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and easy to administer. Several other studies have shown that pancreatic duct stenting (placement of a plastic tube in the pancreatic duct) is an effective intervention in preventing and reducing the severity of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few drawbacks to consider with pancreatic duct stenting: there are some difficulties with insertion of a PD stent, it is associated with a need for radiological follow-up and/or repeat endoscopy for removal, higher cost and a small but important risk of complications (e.g. stent migration). Most of the clinical trials of pancreatic duct stenting were performed, before the results of trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge) has compared the efficacy of pancreatic duct stenting in patients who already received a combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The purpose of this study is to determine the noninferiority of a combination of drug therapies in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis

Keywords

Endoscopic Retrograde Cholangiopancreatography, Pancreatic duct stenting, Post-ERCP pancreatitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pharmacological Prevention

Arm Type

Placebo Comparator

Arm Description

Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting

Arm Title

Pancreatic Stent

Arm Type

Active Comparator

Arm Description

Pancreatic Stent PLUS Pharmacological Prevention

Intervention Type

Device

Intervention Name(s)

Pancreatic Stent

Intervention Description

A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting

Intervention Type

Drug

Intervention Name(s)

Indomethacin

Intervention Description

Indomethacin 100 mg suppository ten minutes before ERCP

Intervention Type

Drug

Intervention Name(s)

Isosorbide Dinitrate

Intervention Description

Sublingual Isosorbide dinitrate 5 mg before ERCP

Intervention Type

Drug

Intervention Name(s)

Ringer's lactate

Intervention Description

IV Ringer's lactate serum with a dose of 6 cc/kg/h during the procedure and 20 cc/kg after ERCP as a bolus dose and 3 cc/kg/h for the next 8 hours.

Primary Outcome Measure Information:

Title

Post-ERCP pancreatitis

Description

Time Frame

24 hours after ERCP

Secondary Outcome Measure Information:

Title

Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)

Description

Time Frame

One week after ERCP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients at high risk of post-ERCP Pancreatitis undergoing ERCP are eligible to enter the study. At least one major or two minor criteria must be present for the patient to be considered at high risk for PEP: Major Sphincter of Oddi dysfunction. History of previous PEP. Pancreatic injection. Precut sphincterotomy. Balloon sphincter dilation without sphincterotomy. Pancreatic guidewire passages > 1. Minor Female patients aged<60 years. Nondilated common bile duct (CBD). Normal serum bilirubin (<2mg/dl). Failure to clear bile duct stones. Failed cannulation. Difficult cannulation (Time to CBD cannulation more than 10 min or more than five attempts at cannulation). Exclusion Criteria: Age younger than 15 years. History of sphincterotomy. Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis). Uncontrolled coagulopathy. Tumor of ampulla of Vater. Those undergoing routine biliary-stent exchange. Acute pancreatitis at the time of ERCP. Chronic pancreatitis. Regular NSAID use during preceding week. Unable to tolerate indomethacin (Creatinine level >1.4 mg/dL or active peptic ulcer disease). Unable to tolerate nitrates (closed-angle glaucoma). Unable to tolerate aggressive hydration (cardiac insufficiency: NYHA FC II or higher, renal insufficiency, electrolyte disturbances, clinical signs of fluid overload including peripheral or pulmonary edema, liver dysfunction with varix>F1, or respiratory insufficiency). Patients requiring pancreatic duct drainage: to bridge dominant strictures, bypass obstructing pancreatic duct stones, drain pseudocysts, seal duct disruptions, pancreatic head cancer with main PD obstruction, IPMN or Pancreas divisum. Known main pancreatic duct stricture toward the head of pancreas. Pregnancy or breastfeeding. Refusal to participate in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rasoul Sotoudehmanesh, MD

Phone

+989121309240

r.sotoudehmanesh@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ali Ali Asgari, MD

Phone

+989123360254

alialiasgari@yahoo.com

Facility Information:

Facility Name

Shariati hospital

City

Tehran

ZIP/Postal Code

1411713135

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rasoul sotoudehmanesh, MD

Phone

+989121309240

r.sotoudehmanesh@gmail.com

First Name & Middle Initial & Last Name & Degree

Ali Ali Asgari, MD

Phone

+989123360254

alialiasgari@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

31454851

Citation

Sotoudehmanesh R, Ali-Asgari A, Khatibian M, Mohamadnejad M, Merat S, Sadeghi A, Keshtkar A, Bagheri M, Delavari A, Amani M, Vahedi H, Nasseri-Moghaddam S, Sima A, Eloubeidi MA, Malekzadeh R. Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial. Endoscopy. 2019 Oct;51(10):915-921. doi: 10.1055/a-0977-3119. Epub 2019 Aug 27.

Results Reference

derived

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Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

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