Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 6:16 AM
Study NCT ID:
NCT01643018
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004444', 'term': 'Echinococcosis, Hepatic'}, {'id': 'D004443', 'term': 'Echinococcosis'}], 'ancestors': [{'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008109', 'term': 'Liver Diseases, Parasitic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D061887', 'term': 'Conversion to Open Surgery'}, {'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cyst recurrence', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '24 months'}, {'measure': 'intraoperative complications', 'timeFrame': '24 hours'}, {'measure': 'late complications', 'timeFrame': '24 months'}, {'measure': 'pain score', 'timeFrame': 'Post opertaive 6th hour, 1, 2, and 7th days', 'description': 'VAS scoring scale will be use'}, {'measure': 'patient comfort/satisfaction', 'timeFrame': '24 months', 'description': 'will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).'}, {'measure': 'hospital stay', 'timeFrame': '10 days', 'description': 'postoperative hospital days'}, {'measure': 'duration of the operation', 'timeFrame': '240 minutes', 'description': 'from incision to closure of the skin'}, {'measure': 'quality of life', 'timeFrame': 'first week, 1, 6, 12, and 24 month after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cystic echinococcosis', 'liver cyst hydatique', 'treatment', 'surgery', 'laparoscopy'], 'conditions': ['Echinococcosis, Hepatic', 'Hydatid Cyst']}, 'descriptionModule': {'briefSummary': '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.\n\nEchinococcosis 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.\n\nThe 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.\n\nThere 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.', 'detailedDescription': 'This is a multicenter, balanced randomization, double blind, active-controlled, parallel-group, non-inferiority study conducted in Turkey (4 sites).\n\nThe 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:\n\nH0: POP - PLAP \\>= M (Open Surgery is superior to Laparoscopic surgery) H1: POP - PLAP \\< M (Laparoscopic surgery is not inferior to open surgery)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients eighteen year-old or older\n* patients diagnosed as cystic echinococcosis of the liver\n* cyst number less then 3\n* cyst size greater than 3 cm\n\nExclusion Criteria:\n\n* previous liver surgery\n* recurrent disease\n* hydatid cyst with multi-organ involvement\n* liver hydatid cyst complicated with infection\n* contraindication for general anesthesia\n* contraindication for laparoscopic surgery\n* patient younger than 18\n* allergy to albendazole'}, 'identificationModule': {'nctId': 'NCT01643018', 'briefTitle': 'Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver', 'organization': {'class': 'OTHER', 'fullName': 'Medical Park Gaziantep Hospital'}, 'officialTitle': 'Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety', 'orgStudyIdInfo': {'id': 'MK-001-CH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laparoscopic surgery', 'description': '-Laparoscopic surgery group describes the patients treated with laparoscopic surgery', 'interventionNames': ['Procedure: laparoscopic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Surgery', 'description': '-open surgery group describes the patients treated with traditional open surgery', 'interventionNames': ['Procedure: open surgery']}], 'interventions': [{'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopy'], 'description': '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.', 'armGroupLabels': ['laparoscopic surgery']}, {'name': 'open surgery', 'type': 'PROCEDURE', 'otherNames': ['laparotomy', 'open'], 'description': '-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.', 'armGroupLabels': ['Open Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27090', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hatem Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '27090', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Medical Park Gaziantep Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '27100', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': '25 Aralık State Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '27100', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Dr.Ersin Aslan State Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'MEHMET KAPLAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Park Gaziantep Hospital, Gaziantep, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Park Gaziantep Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MKaplan', 'investigatorFullName': 'Mehmet Kaplan', 'investigatorAffiliation': 'Medical Park Gaziantep Hospital'}}}}