Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-02-17 @ 10:46 PM
Study NCT ID:
NCT05500157
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536330', 'term': 'Polycystic liver disease'}, {'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PLD-Q 4 weeks', 'timeFrame': '4 weeks after the procedure', 'description': 'Comparison of PLD-Q scores 4 weeks after the procedure, adjusted for baseline PLD-Q score.'}], 'secondaryOutcomes': [{'measure': 'PLD-Q score 1, 6 and 12 months after intervention', 'timeFrame': 'up to 12 months', 'description': 'PLD-Q score at 1, 6 and 12 months after intervention, adjusted for baseline'}, {'measure': 'PLD-Q invididual symptoms', 'timeFrame': 'up to 12 months', 'description': 'PLD-Q individual symptom scores at 1, 6 and 12 months after intervention, compared to baseline'}, {'measure': 'SF-36 MCS', 'timeFrame': 'up to 12 months', 'description': 'SF-36 Mental Component Score at 1, 6 and 12 months after intervention, adjusted to baseline'}, {'measure': 'SF 36 PCS', 'timeFrame': 'up to 12 months', 'description': 'SF-36 Physical Component Score at 1, 6 and 12 months after intervention, adjusted to baseline'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'up to 12 months', 'description': 'EQ-5D-5L score at 1, 6 and 12 months after intervention, adjusted to baseline'}, {'measure': 'Liver and cyst volume', 'timeFrame': 'up to 12 months', 'description': 'Liver and cyst volume with CT before and 12 months after the intervention'}, {'measure': 'Liver and cyst volume at recurrence', 'timeFrame': 'up to 12 months', 'description': 'Liver and cyst volume in cases of recurrence of symptoms'}, {'measure': 'Cyst volume with US', 'timeFrame': 'up to 12 months', 'description': 'Cyst volume with ultrasound, at baseline and 1, 6 and 12 months after intervention.'}, {'measure': 'Adverse events', 'timeFrame': 'up to 12 months', 'description': 'Adverse events (according to Clavien-Dindo)'}, {'measure': 'Technical success', 'timeFrame': 'periprocedural', 'description': 'Technical success'}, {'measure': 'Hospital stay', 'timeFrame': 'periprocedural', 'description': 'Hospital stay in days'}, {'measure': 'Re-intervention rates', 'timeFrame': 'up to 12 months', 'description': 'Re-intervention rates during 12 months follow-up.'}, {'measure': 'Cost-effectiveness iPCQ', 'timeFrame': 'up to 12 months', 'description': 'Cost-effectiveness of both procedures iPCQ 1, 6 and 12 months after intervention, adjusted for baseline'}, {'measure': 'Cost-effectiveness iMCQ', 'timeFrame': 'up to 12 months', 'description': 'Cost-effectiveness of both procedures iMCQ 1, 6 and 12 months after intervention, adjusted for baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polycystic liver disease', 'aspiration sclerotherapy', 'fenestration'], 'conditions': ['Liver Cyst', 'Polycystic Liver Disease', 'Autosomal Dominant Polycystic Kidney', 'Autosomal Dominant Polycystic Liver Disease']}, 'descriptionModule': {'briefSummary': 'Patients with large hepatic cysts (\\> 5cm) may develop symptoms. These can be captured with the polycystic liver disease questionnaire (PLD-Q). Treatment of large hepatic cysts consists of aspiration sclerotherapy or laparoscopic fenestration.\n\nThe safety and efficacy of both procedures has been explored in two recent systematic reviews yet no evident conclusion regarding superiority of either procedure could be drawn.\n\nThe main objective of the ATLAS trial is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes.', 'detailedDescription': "Rationale: Patients with large hepatic cysts(\\>5cm) may develop symptoms due to distention of Glisson's capsule and/or compression on other abdominal organs. Frequently reported symptoms include abdominal pain, early satiety, nausea, and dyspnea. These symptoms can be captured in the disease-specific Polycystic Liver Disease Questionnaire (PLD-Q), a validated instrument. The treatment of symptomatic liver cysts is aimed to improve symptoms and quality of life by reducing cyst volume. There are two procedures available to treat symptomatic liver cysts: percutaneous aspiration sclerotherapy and laparoscopic fenestration.\n\nIn aspiration sclerotherapy, fluid is evacuated from the liver cyst and subsequently the cyst lining is exposed to a sclerosing agent for a limited period of time. Sclerotherapy causes temporary recurrence of cyst fluid after drainage, but subsequently results in a steady decrease of cyst volume in the majority of patients.\n\nIn laparoscopic fenestration the liver is exposed through laparoscopic surgery. In this procedure the cyst is punctured and drained followed by resection of extra-hepatic cyst wall.\n\nThe safety and efficacy of aspiration sclerotherapy and laparoscopic fenestration have been explored in two recent systematic reviews. No evident conclusion could be drawn because of the retrospective study design in the vast majority of the studies and the heterogeneity among these. A randomized controlled trial is warranted to identify the possible differences in safety and efficacy in aspiration sclerotherapy and laparoscopic fenestration.\n\nHypothesis: The investigators expect patients treated with laparoscopic fenestration to have better clinical outcome; i.e. a lower PLD-Q score, compared to aspiration sclerotherapy, when measured 4 weeks after the procedure. The investigators expect this difference to become smaller over time (after 6 and 12 months), with loss of statistical significance.\n\nObjective: The main objective is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes. This information can be used to assess cost-effectiveness in both treatments.\n\nStudy design: A prospective, randomized clinical superiority trial in which patients will be randomized 1:1 to one of the treatment arms. Patients will be followed for 1 year.\n\nStudy population: All patients ≥18 years who are diagnosed with a dominant, simple hepatic cyst (\\>5 cm in diameter), that are symptomatic (PLD-Q score ≥20) and have an indication for treatment (both aspiration sclerotherapy and laparoscopic fenestration) are suitable for inclusion in this study. Only patients that are eligible for both treatments can be included in this study. In particular, patients with multiple cysts (\\>20 cysts of \\>1.5 cm) will be excluded as surgery leads to more complications in these patients.\n\nIntervention: Patients will be randomly allocated to either aspiration sclerotherapy or laparoscopic fenestration. Both procedures are performed according to the standard Radboudumc protocols. Aspiration sclerotherapy consists of ultrasound-guided, percutaneous drainage of the cyst with subsequent sclerosation with ethanol. Laparoscopic fenestration consists of standard abdominal laparoscopy in which the large cyst(s) are drained and deroofed.\n\nMain study parameters: The main study parameter is the PLD-Q score at 4 weeks after treatment. Secondary parameters are among others: PLD-Q score at baseline, 6 months and 12 months; liver volume (CT) at baseline and 4 weeks; cyst volume (ultrasound) at baseline, 4 weeks, 6 months and 12 months; complications according to Clavien-Dindo; admission duration, recurrence and re-intervention rates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Hepatic cyst characteristics:\n\n * Large (\\>5 cm),\n * Symptomatic (PLD-Q score ≥20),\n * Non-parasitic on imaging (US/CT/MRI)\n * Non-neoplastic on imaging (US/CT/MRI)\n* Providing informed consent\n\nExclusion Criteria:\n\n* Clinical indication of a complicated hepatic cyst (cyst rupture or active cyst infection)\n* Cyst is not laparoscopically accessible for surgery\n* Cyst is not percutaneously (ultrasound-guided) accessible for aspiration\n* More than 20 cysts of \\>1.5 cm\n* Age above 75 years\n* ASA IV\n* ECOG score \\>1\n* Aspiration sclerotherapy or laparoscopic fenestration of hepatic cysts was performed in the last 6 months.\n* Severe renal impairment (eGFR \\< 30 ml/min/1,73 m2)\n* Coagulopathy (spontaneous INR \\>2 or platelet count \\< 80 x 109/l)\n* Radiologic contrast allergy\n* Pregnancy\n* Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator (e.g. inability to fill out questionnaires).'}, 'identificationModule': {'nctId': 'NCT05500157', 'acronym': 'ATLAS', 'briefTitle': 'Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts (ATLAS): a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '2020-7134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspiration sclerotherapy', 'description': 'Aspiration sclerotherapy is a percutaneous procedure that evacuates fluid from the liver cyst and subsequently exposes cyst lining to a sclerosing agent (e.g. ethanol, minocycline) for a limited period of time.', 'interventionNames': ['Procedure: aspiration sclerotherapy versus laparoscopic fenestration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Fenestration', 'description': 'Laparoscopic fenestration exposes the liver through laparoscopic surgery. During this procedure the cyst is punctured and drained followed by resection of the extra-hepatic cyst wall', 'interventionNames': ['Procedure: aspiration sclerotherapy versus laparoscopic fenestration']}], 'interventions': [{'name': 'aspiration sclerotherapy versus laparoscopic fenestration', 'type': 'PROCEDURE', 'description': 'See arm description', 'armGroupLabels': ['Aspiration sclerotherapy', 'Laparoscopic Fenestration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Radboudumc University M Center', 'role': 'CONTACT', 'email': 'joost.drenth@radboudumc.nl', 'phone': '+31644107787'}], 'facility': 'Radboudumc University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Joost P.H. Drenth', 'role': 'CONTACT', 'email': 'joostphdrenth@cs.com', 'phone': '+31 24 3619190'}, {'name': 'Thijs Barten', 'role': 'CONTACT', 'email': 'thijs.rm.barten@radboudumc.nl', 'phone': '+31 24 8186542'}], 'overallOfficials': [{'name': 'Joost P.H. Drenth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Study data will be provided upon reasonable request with the principal investigator', 'ipdSharing': 'YES', 'description': 'Individual participant data are available to other researchers for clinical research purposes upon reasonable request to the principal investigator', 'accessCriteria': 'Study data will be provided upon reasonable request with the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}