Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver

Echinococcosis, Hepatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643018
• Other study ID #: MK-001-CH
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: July 16, 2012
• Start date: November 2006
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Medical Park Gaziantep Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Echinococcosis, Hepatic
• Hydatid Cyst

Intervention

Procedure:
• laparoscopic surgery
In laparoscopy group three trocars is used. The first is 10 mm and inserted within the umbilicus for telescop, the second is 10 mm and inserted just below the xiphoid process, and third is 5 mm and inserted at the right upper quadrant of the abdomen.
• open surgery
-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.

Locations

Country	Name	City	State
Turkey	25 Aralik State Hospital	Gaziantep
Turkey	Dr.Ersin Aslan State Hospital	Gaziantep
Turkey	Hatem Hospital	Gaziantep
Turkey	Medical Park Gaziantep Hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Medical Park Gaziantep Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cyst recurrence		24 months	Yes
Secondary	mortality		24 months	Yes
Secondary	intraoperative complications		24 hours	Yes
Secondary	late complications		24 months	Yes
Secondary	pain score	VAS scoring scale will be use	Post opertaive 6th hour, 1, 2, and 7th days	Yes
Secondary	patient comfort/satisfaction	will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).	24 months	No
Secondary	hospital stay	postoperative hospital days	10 days	No
Secondary	duration of the operation	from incision to closure of the skin	240 minutes	No
Secondary	quality of life		first week, 1, 6, 12, and 24 month after operation	No

External Links

•   mehmet kaplan