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Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Primary Purpose

Acute Cholangitis

Status

Recruiting

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

ERCP

About this trial

This is an interventional treatment trial for Acute Cholangitis

Eligibility Criteria

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

Inclusion Criteria: Patients who met criteria for a definite diagnosis acute cholangitis. Exclusion Criteria: Patients with severe acute cholangitis at admission. Age < 18 years. Pregnancy. Associated Acute Severe Pancreatitis. Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage. Not giving consent.

Sites / Locations

AIG HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Urgent ERCP

Early ERCP

Arm Description

Urgent ERCP (<24 Hours).

Early ERCP(24 to 48 Hours).

Outcomes

Primary Outcome Measures

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

To perform a single-centre, randomized trial comparing the efficacy (the ability to produce a desired or intended result) of urgent versus early ERCP (Endoscopic retrograde cholangiopancreatography) for reducing the risk of 30 days of mortality.

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

PRIMARY OUTCOME: 30 day mortality

Secondary Outcome Measures

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

Organ failure. In Hospital mortality. Hospital stay. Need for reintervention. Need for readmission.

Full Information

NCT ID

NCT05920954

First Posted

May 23, 2023

Last Updated

July 26, 2023

Sponsor

Asian Institute of Gastroenterology, India

1. Study Identification

Unique Protocol Identification Number

NCT05920954

Brief Title

Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Official Title

Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 30, 2023 (Actual)

Primary Completion Date

March 15, 2025 (Anticipated)

Study Completion Date

March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure. Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.

6. Conditions and Keywords

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

Acute Cholangitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Urgent ERCP

Arm Type

Experimental

Arm Description

Urgent ERCP (<24 Hours).

Arm Title

Early ERCP

Arm Type

Experimental

Arm Description

Early ERCP(24 to 48 Hours).

Intervention Type

Procedure

Intervention Name(s)

ERCP

Intervention Description

Repeat ERCP

Primary Outcome Measure Information:

Title

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

Description

Time Frame

Two Years

Title

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

Description

PRIMARY OUTCOME: 30 day mortality

Time Frame

Two Years

Secondary Outcome Measure Information:

Title

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

Description

Organ failure. In Hospital mortality. Hospital stay. Need for reintervention. Need for readmission.

Time Frame

Two Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

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

Hardik Rughwani, MD, DM

Phone

9426928600

Ext

+91

hardik.hr@gmail.com

Facility Information:

Facility Name

AIG Hospitals

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500032

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hardik RAMESH RUGHWANI, DM

Phone

9426928600

hardik.hr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

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