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

Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety

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.

Study Overview

• Status: Completed
• Conditions: Echinococcosis, Hepatic; Hydatid Cyst
• Intervention / Treatment: Procedure: laparoscopic surgery; Procedure: open surgery

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)

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27090
    • Hatem Hospital
  • Gaziantep, Turkey, 27090
    • Medical Park Gaziantep Hospital
  • Gaziantep, Turkey, 27100
    • 25 Aralık State Hospital
  • Gaziantep, Turkey, 27100
    • Dr.Ersin Aslan State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: laparoscopic surgery; -Laparoscopic surgery group describes the patients treated with laparoscopic surgery	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.; Other Names: Laparoscopy
ACTIVE_COMPARATOR: Open Surgery; -open surgery group describes the patients treated with traditional open surgery	Procedure: open surgery; -open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.; Other Names: laparotomy; open

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cyst recurrence	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		24 months
intraoperative complications		24 hours
late complications		24 months
pain score	VAS scoring scale will be use	Post opertaive 6th hour, 1, 2, and 7th days
patient comfort/satisfaction	will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).	24 months
hospital stay	postoperative hospital days	10 days
duration of the operation	from incision to closure of the skin	240 minutes
quality of life		first week, 1, 6, 12, and 24 month after operation

Collaborators and Investigators

• Sponsor: Medical Park Gaziantep Hospital
• Investigators: Principal Investigator: Mehmet KAPLAN, MD, Medical Park Gaziantep Hospital, Gaziantep, Turkey

Publications and helpful links

Helpful Links

• mehmet kaplan

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (ESTIMATE): July 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: treatment; surgery; laparoscopy; cystic echinococcosis; liver cyst hydatique
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Liver Diseases; Parasitic Diseases; Helminthiasis; Cestode Infections; Liver Diseases, Parasitic; Echinococcosis; Echinococcosis, Hepatic
• Other Study ID Numbers: MK-001-CH