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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Kaplan, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier:
NCT01643018
First received: June 26, 2012
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Echinococcosis, Hepatic
Hydatid Cyst
Procedure: laparoscopic surgery
Procedure: open surgery

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

Resource links provided by NLM:


Further study details as provided by Medical Park Gaziantep Hospital:

Primary Outcome Measures:
  • cyst recurrence [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • intraoperative complications [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • late complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • pain score [ Time Frame: Post opertaive 6th hour, 1, 2, and 7th days ] [ Designated as safety issue: Yes ]
    VAS scoring scale will be use

  • patient comfort/satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).

  • hospital stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    postoperative hospital days

  • duration of the operation [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]
    from incision to closure of the skin

  • quality of life [ Time Frame: first week, 1, 6, 12, and 24 month after operation ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: November 2006
Study Completion Date: May 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643018

Locations
Turkey
25 Aralık State Hospital
Gaziantep, Turkey, 27100
Dr.Ersin Aslan State Hospital
Gaziantep, Turkey, 27100
Hatem Hospital
Gaziantep, Turkey, 27090
Medical Park Gaziantep Hospital
Gaziantep, Turkey, 27090
Sponsors and Collaborators
Medical Park Gaziantep Hospital
Investigators
Principal Investigator: MEHMET KAPLAN, MD Medical Park Gaziantep Hospital, Gaziantep, Turkey
  More Information

Additional Information:
No publications provided

Responsible Party: Mehmet Kaplan, MKaplan, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier: NCT01643018     History of Changes
Other Study ID Numbers: MK-001-CH
Study First Received: June 26, 2012
Last Updated: July 16, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Medical Park Gaziantep Hospital:
cystic echinococcosis
liver cyst hydatique
treatment
surgery
laparoscopy

Additional relevant MeSH terms:
Echinococcosis
Echinococcosis, Hepatic
Cestode Infections
Digestive System Diseases
Helminthiasis
Liver Diseases
Liver Diseases, Parasitic
Parasitic Diseases

ClinicalTrials.gov processed this record on November 20, 2014