Echinococcosis, HepaticNCT01643018
Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver
A study testing laparoscopic surgery and open surgery in people with Echinococcosis, Hepatic and Hydatid Cyst, run by Medical Park Gaziantep Hospital at 4 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Echinococcosis, Hepatic, Hydatid Cyst
- What is being tested?
- laparoscopic surgery and open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Nov 2006to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Hatem Hospital
Gaziantep, 27090
Medical Park Gaziantep Hospital
Gaziantep, 27090
25 Aralık State Hospital
Gaziantep, 27100
Dr.Ersin Aslan State Hospital
Gaziantep, 27100
About this study
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.
Read more
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.
Read the 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)
- Conditions
- Echinococcosis, Hepatic, Hydatid Cyst
- Being tested
- laparoscopic surgery, open surgery
- Keywords
- cystic echinococcosis, liver cyst hydatique, treatment, surgery, laparoscopy
- Medical subject headings
- Echinococcosis, Hepatic, Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
Also called Laparoscopy
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 surgeryProcedure or surgery
Also called laparotomy, open
-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery | Experimental | -Laparoscopic surgery group describes the patients treated with laparoscopic surgery Receives: Procedure: laparoscopic surgery |
| Open Surgery | Active comparator | -open surgery group describes the patients treated with traditional open surgery Receives: Procedure: open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cyst recurrence
Measured: 24 months
Secondary outcomes (8)
mortality
Measured: 24 months
intraoperative complications
Measured: 24 hours
late complications
Measured: 24 months
pain score
VAS scoring scale will be use
Measured: 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).
Measured: 24 months
hospital stay
postoperative hospital days
Measured: 10 days
duration of the operation
from incision to closure of the skin
Measured: 240 minutes
quality of life
Measured: first week, 1, 6, 12, and 24 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2006
- Primary completionNov 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echinococcosis, HepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- MEHMET KAPLAN, MD, Principal investigator, Medical Park Gaziantep Hospital, Gaziantep, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643018
- Sponsor's protocol ID
- MK-001-CH
- Status last verified
- Jul 2012
- First submitted
- 26 Jun 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01643018
- Acronym / sponsor ID
- MK-001-CH
- Conditions
- Echinococcosis, Hepatic, Hydatid Cyst
- Keywords
- cystic echinococcosis, liver cyst hydatique, treatment, surgery, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Medical Park Gaziantep HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | Experimental | Procedure: laparoscopic surgery-Laparoscopic surgery group describes the patients treated with laparoscopic surgery |
| Open Surgery | Active comparator | Procedure: open surgery-open surgery group describes the patients treated with traditional open surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- previous liver surgery
- recurrent disease
- hydatid cyst with multi-organ involvement
- liver hydatid cyst complicated with infection
- contraindication for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic surgeryAlso: LaparoscopyIn 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. | Procedure or surgery | laparoscopic surgery |
| open surgeryAlso: laparotomy, open-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used. | Procedure or surgery | Open Surgery |
Primary outcome
cyst recurrence
Time frame: 24 months
8 secondary outcomes
mortality
Time frame: 24 months
intraoperative complications
Time frame: 24 hours
late complications
Time frame: 24 months
pain score
Time frame: Post opertaive 6th hour, 1, 2, and 7th days
patient comfort/satisfaction
Time frame: 24 months
hospital stay
Time frame: 10 days
duration of the operation
Time frame: 240 minutes
quality of life
Time frame: first week, 1, 6, 12, and 24 month after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET KAPLAN, MD principal investigator
Medical Park Gaziantep Hospital, Gaziantep, Turkey
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic surgery and open surgery in people with Echinococcosis, Hepatic and Hydatid Cyst, run by Medical Park Gaziantep Hospital at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cyst recurrence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.