Jaundice as Initial Presentation of Liver Hydatidosis (ICTEHIDA)

Jaundice Clinical Trial

— ICTEHIDA  

Official title:

Liver Echinococcosis; Jaundice as Initial Presentation, Short and Long Term Results of Surgical Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04271176
• Other study ID #: UE-CHUB 002-2020
• Status: Active, not recruiting
• Start date: January 1, 2009
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2020
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate patients with hepatic hydatidosis whose symptom at diagnosis was obstructive jaundice. As well as analyzing, the rate of performing preoperative ERCP, the results after surgery and morbidity

Description:

Retrospective study of patients operated on for liver hydatidosis and whose initial symptom was obstructive jaundice Study period: January 2006 to September 2018

The preoperative diagnosis was based on abdominal ultrasound (US), CT scan or magnetic nuclear resonance

Surgical technique Precautions are taken to avoid the spillage of the parasite in the abdominal cavity. The peritoneal cavity is liberally protected with scolicidal agents. All patients have intraoperative ultrasound. Ultrasound is performed to locate the presence of any cysts which might not be seen by the preoperative imaging. Intraoperative ultrasound is also used to find out the relation of the cyst to the big vessels. Depending on the intraoperative findings, the location and size of the cyst will be considered the type of surgery to be performed. Radical surgery (closed and open total cystopericystectomy, or liver resection) or conservative surgery (partial cystopericystectomy, removal of the vesicles with external or internal drainage). When the cyst affects a total lobe and / or the main pedicles, a hepatectomy is performed.

The demographic data of the patients will be taken from their clinical histories. It included age, sex, medical history of hidatidosis, clinical findings, laboratory data, radiological findings, endoscopic treatment, surgical treatment.

The investigators will analyze postoperative mortality and morbidity. Complications' ranking according to the Clavien-Dindo score, 'severe complication' is defined as greater or equal to IIIa

Follow-up The follow-up of these patients will be performed with ultrasound or CT and hydatid serology. The minimum follow-up of the patients is six months. Relapse is defined as the appearance of new active liver cysts after the patient had undergone surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: April 30, 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hepatic Hydatidosis with obstructive jaundice surgically treated

Exclusion Criteria:

• Patients with conservative treatment

Related Conditions & MeSH terms

• Echinococcosis, Hepatic
• Hepatic Echinococcosis
• Jaundice

Locations

Country	Name	City	State
Spain	Universidad de Extremadura- Facultad de Medicina	Badajoz

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Extremadura	Complejo Hospitalario Universitario de Badajoz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Postoperative morbidity after surgical treatment	90 days