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Jaundice as Initial Presentation of Liver Hydatidosis (ICTEHIDA) (ICTEHIDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271176
Recruitment Status : Active, not recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Complejo Hospitalario Universitario de Badajoz
Information provided by (Responsible Party):
Gerardo Blanco-Fernández, Universidad de Extremadura

Brief 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

Condition or disease
Hepatic Echinococcosis Jaundice

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Liver Echinococcosis; Jaundice as Initial Presentation, Short and Long Term Results of Surgical Treatment
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Morbidity [ Time Frame: 90 days ]
    Postoperative morbidity after surgical treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients operated on hydatidic cyst, any surgical option
Criteria

Inclusion Criteria:

  • Hepatic Hydatidosis with obstructive jaundice surgically treated

Exclusion Criteria:

  • Patients with conservative treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271176


Locations
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Spain
Universidad de Extremadura- Facultad de Medicina
Badajoz, Spain, 06080
Sponsors and Collaborators
Universidad de Extremadura
Complejo Hospitalario Universitario de Badajoz
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Responsible Party: Gerardo Blanco-Fernández, Chief of Department, Universidad de Extremadura
ClinicalTrials.gov Identifier: NCT04271176    
Other Study ID Numbers: UE-CHUB 002-2020
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerardo Blanco-Fernández, Universidad de Extremadura:
Jaundice
Echinococcosis
Liver
Surgical treatment
Additional relevant MeSH terms:
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Echinococcosis
Echinococcosis, Hepatic
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Cestode Infections
Helminthiasis
Parasitic Diseases
Liver Diseases, Parasitic
Liver Diseases
Digestive System Diseases