Clinical trial NCT01643018: Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver
Official title: Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Echinococcosis, Hepatic
Hydatid Cyst
Keywords: cystic echinococcosis
liver cyst hydatique
treatment
surgery
laparoscopy
Lead sponsor: Medical Park Gaziantep Hospital
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing extensive organ damage and even death of the patient.

Echinococcosis is one of the most neglected parasitic diseases and the lack of the prospective randomised studies supports this idea. Development of new drugs and other treatment modalities receives very little attention, if any. In most developed countries, Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and is found almost exclusively in migrants from endemic regions. In endemic regions, predominantly settings with limited resources, patient numbers are high.

The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure of the disease. It has to be done with a minimal risk and maximum comfort for the patient, and always paying attention to avoid complications, secondary hydatidosis, and relapses.

There are several treatment modalities. Of them the most preferred surgical method is traditional cyst management through a laparotomy incision. Same can be done with laparoscopy. In the past 15 years significant advances in laparoscopic surgical skills and techniques combined with explosive advances in laparoscopic technology have encouraged the application of laparoscopy to the evaluation and treatment of solid organs including the liver. There are many studies about the laparoscopic treatment of liver hydatid cyst published in the literature and the feasibility of this procedure has been demonstrated by them. While the majority of them are case reports or case series, there are some relatively large series comparing open versus laparoscopic surgery published in the last decade, which all are not randomized trial.

Detailed description: This is a multicenter, balanced randomization, double blind, active-controlled, parallel-group, non-inferiority study conducted in Turkey (4 sites).

The objective of this trial is to show there is no difference in rate of recurrence 2 years after laparoscopic as compared to open management of cystic echinococcosis of the liver, by at least M (non-inferiority margin). If PLAP/POP: denotes the cure rate in the laparoscopy group (LAP) / open group (OP), then the following two-sided test problem is assessed:

H0: POP - PLAP \>= M (Open Surgery is superior to Laparoscopic surgery) H1: POP - PLAP \< M (Laparoscopic surgery is not inferior to open surgery)

Eligibility criteria: Inclusion Criteria:

* patients eighteen year-old or older
* patients diagnosed as cystic echinococcosis of the liver
* cyst number less then 3
* cyst size greater than 3 cm

Exclusion Criteria:

* previous liver surgery
* recurrent disease
* hydatid cyst with multi-organ involvement
* liver hydatid cyst complicated with infection
* contraindication for general anesthesia
* contraindication for laparoscopic surgery
* patient younger than 18
* allergy to albendazole

Primary outcomes:
measure: cyst recurrence
timeFrame: 24 months
Secondary outcomes:
measure: mortality
timeFrame: 24 months
measure: intraoperative complications
timeFrame: 24 hours
measure: late complications
timeFrame: 24 months
measure: pain score
timeFrame: Post opertaive 6th hour, 1, 2, and 7th days
measure: patient comfort/satisfaction
timeFrame: 24 months
measure: hospital stay
timeFrame: 10 days
measure: duration of the operation
timeFrame: 240 minutes
measure: quality of life
timeFrame: first week, 1, 6, 12, and 24 month after operation
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hatem Hospital
city: Gaziantep
country: Turkey
facility: Medical Park Gaziantep Hospital
city: Gaziantep
country: Turkey
facility: 25 Aralık State Hospital
city: Gaziantep
country: Turkey
facility: Dr.Ersin Aslan State Hospital
Study officials:
affiliation: Medical Park Gaziantep Hospital, Gaziantep, Turkey
name: MEHMET KAPLAN, MD
role: PRINCIPAL_INVESTIGATOR
References: