Ultrasound Guided Percutaneous Cholecystostomy.

Gall Bladder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05927870
• Other study ID #: percutaneous cholecystostomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: Basma Fawzy Abd Elhameed, Resident doctor
• Phone: 01062649652
• Email: basmafawzy80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 100 Years

Eligibility

Inclusion Criteria:

• Pyocele of the gallbladder

• Mucocele of the gallbladder

• Perforated gallbladder

• Malignant causes of gallbladder obstruction

Exclusion Criteria:

• Uncontrolled bleeding disorders

Related Conditions & MeSH terms

• Gall Bladder Disease
• Gallbladder Diseases
• Urinary Bladder Diseases

Intervention

Procedure:
• pigtail
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	basline

External Links

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