NCT06191471

Brief Summary

41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

December 20, 2023

Last Update Submit

December 20, 2023

Conditions

Keywords

Acute acalculous cholecystitis

Outcome Measures

Primary Outcomes (1)

  • Hepatitis A induced acute acalculous cholecystitis

    Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis

    1 month

Interventions

Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting with symptoms of acute acalculous cholecystitis

You may qualify if:

  • acalculous cholecystitis

You may not qualify if:

  • calculous cholecystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of balamand

Beirut, Lebanon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gallbladder

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

November 1, 2023

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Publishing a case report

Locations