Biliary Fistula and Late Recurrence of Liver Hydatid Cyst: Role of Cysto-biliary Communication

NCT05116735 | Completed

• 1 other identifier: hydatid cyst in liver
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose : The primary goals of this study were to determine the prevalence and risk factors of occult CBC and recurrence, as well as the relationship between occult cysto-biliary communications manifested as postoperative biliary leakage and recurrence. The secondary goal was to use chemical analysis of hydatid cyst fluid to assess excessive bilirubin and alkaline phosphatase levels as predictors of fistula and recurrence. Methods: This prospective multi-center experimental and follow-up study of six years duration was conducted at the hepato-biliary pancreatic units of our universities hospitals from September 2010 to September 2016. Initially, 292 patients were included, but only 244 patients enrolled in the final study.

Conditions

Liver Surgery

Outcome Measures

Primary Outcomes (2)

• biliary leakage

  incidence of biliary leakage detected clinically, sonar or CT

  30 days postoperatively

• recurrence

  detection of recurrence by CT and sonar abdomen

  5 years

Secondary Outcomes (1)

• biochemical analysis of hydatid cyst fluid

  intraoperative

Study Arms (1)

laparoscopic partial cystectomy with omentoplasty

EXPERIMENTAL

laparoscopic partial cystectomy with omentoplasty

Procedure: laparoscopic partial cystectomy with omentoplasty

Interventions

laparoscopic partial cystectomy with omentoplasty PROCEDURE

laparoscopic partial cystectomy with omentoplasty

laparoscopic partial cystectomy with omentoplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stages CE2
• CE3b According to the WHO-IWGE classification
• solitary
• symptomatic or asymptomatic
• superficial cyst
• cases not suited for hepatic resection as the cyst wall abutting critical vascular and biliary structures as hepatic resection is harmful or excessive loss of hepatic tissue

You may not qualify if:

• stages CL, CE1, CE3a, CE4, CE5 according to WHO-IWGE classification of the hydatid cyst
• preoperative total bilirubin level greater than 2.0 mg/dl and direct bilirubin level greater than 1.5 mg/dl
• common bile duct dilatation greater than 10 mm , or CT, or MRI, previous percutaneous treatment
• recurrent cases after any type of surgery, cases with associated extrahepatic or extra-abdominal hydatid cyst
• cysts affecting an entire lobe or the main pedicles
• stages Cysts that are complicated (ruptured or diseased cysts), deep cysts .Patients who refuse intervention, have a surgical contraindication, are pregnant, have hydatid cysts in both lobes of the liver, previous liver surgery, liver abscess, frank CBC, cases lost during follow-up, cases who refused to take albendazole, or cases who developed albendazole-related issues (disturbed liver function).

Sponsors & Collaborators

• Zagazig University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 11, 2021
• Study Start: September 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2021
• Last Updated: June 28, 2023

Record last verified: 2023-06