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