Skip to main content
OpenTrials
Completed

NCT Number: NCT01643018

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

25 Aralık State Hospital, Gaziantep, Turkey (Türkiye)

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

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

Open Surgery

Procedure

-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

Primary outcomes

  1. cyst recurrence

    Time frame: 24 months

Secondary outcomes

  1. mortality

    Time frame: 24 months

  2. intraoperative complications

    Time frame: 24 hours

  3. late complications

    Time frame: 24 months

  4. pain score

    Time frame: Post opertaive 6th hour, 1, 2, and 7th days

    VAS scoring scale will be use

  5. patient comfort/satisfaction

    Time frame: 24 months

    will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).

  6. hospital stay

    Time frame: 10 days

    postoperative hospital days

  7. duration of the operation

    Time frame: 240 minutes

    from incision to closure of the skin

  8. quality of life

    Time frame: first week, 1, 6, 12, and 24 month after operation

Sponsors and collaborators

Lead sponsor

Medical Park Gaziantep Hospital

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Jul 17, 2012
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.