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Ultrasound Guided Percutaneous Cholecystostomy.

Primary Purpose

Gall Bladder Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

pigtail

About this trial

This is an interventional treatment trial for Gall Bladder Disease

Eligibility Criteria

4 Years - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Pyocele of the gallbladder Mucocele of the gallbladder Perforated gallbladder Malignant causes of gallbladder obstruction Exclusion Criteria: Uncontrolled bleeding disorders

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pyocele

Arm Description

obstructed gallbladder with infection on top

Outcomes

Primary Outcome Measures

value of cholecystostomy as preoperative step in critically ill patients

The aim of this study was to assess the clinical outcomes of PCT use, with particular emphasis on a subgroup of patients who did not proceed to cholecystectomy.

Secondary Outcome Measures

Full Information

NCT ID

NCT05927870

First Posted

June 23, 2023

Last Updated

July 12, 2023

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05927870

Brief Title

Ultrasound Guided Percutaneous Cholecystostomy.

Official Title

Ultrasound Guided Percutaneous Cholecystostomy as Preoperative Step for Obstructive Gallbladder Diseases.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease

Detailed Description

The etiology of biliary obstruction can be benign or malignant. Benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients [5], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children [6]. Obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children [7]. Biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients [8]. The question remains as to whether all patients undergoing PCT drainage require a definitive cholecystectomy. Previous publications have suggested that there is a reluctance to use PCT in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.

6. Conditions and Keywords

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

Gall Bladder Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pyocele

Arm Type

Experimental

Arm Description

obstructed gallbladder with infection on top

Intervention Type

Procedure

Intervention Name(s)

pigtail

Intervention Description

placing a small amount of local anaesthetic subcutaneously at the site of the gallbladder, a skin incision was made through which the catheter was introduced. A 7-Fr pigtail catheter was used in all cases . If possible, the catheter was introduced into the gallbladder after passing through the liver. The catheter was thereafter fixed, either by an internal locking device or by means of a suture to the skin. The catheter was rinsed with saline solution daily in order to prevent clogging.

Primary Outcome Measure Information:

Title

value of cholecystostomy as preoperative step in critically ill patients

Description

The aim of this study was to assess the clinical outcomes of PCT use, with particular emphasis on a subgroup of patients who did not proceed to cholecystectomy.

Time Frame

basline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pyocele of the gallbladder Mucocele of the gallbladder Perforated gallbladder Malignant causes of gallbladder obstruction Exclusion Criteria: Uncontrolled bleeding disorders

Central Contact Person:

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

Basma Fawzy Abd Elhameed, Resident doctor

Phone

01062649652

basmafawzy80@gmail.com

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

Mostafa Hashem Mahmoud Othman, professor

Phone

01000684012

hashemradiol@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

12204405

Citation

Akhan O, Akinci D, Ozmen MN. Percutaneous cholecystostomy. Eur J Radiol. 2002 Sep;43(3):229-36. doi: 10.1016/s0720-048x(02)00158-4.

Results Reference

background

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/12204405/

Description

Related Info

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