Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 8:21 AM
Study NCT ID:
NCT02086669
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumatic Dilatation or Surgical Myotomy for Achalasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074434', 'term': 'Heller Myotomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074432', 'term': 'Sphincterotomy'}, {'id': 'D000074433', 'term': 'Myotomy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failures', 'timeFrame': 'At least five years after intervention', 'description': 'Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.'}], 'secondaryOutcomes': [{'measure': 'Dysphagia scoring', 'timeFrame': 'At least five years after intervention', 'description': 'Dysphagia score according to standardized, validated scoring system.'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'At least five years after intervention.', 'description': 'Universally adopted and validated instruments are used.'}, {'measure': 'Direct medical costs.', 'timeFrame': 'At least five years after intervention.', 'description': 'Charges for the average hospital in respective countries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Achalasia']}, 'referencesModule': {'references': [{'pmid': '25409838', 'type': 'DERIVED', 'citation': 'Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.'}]}, 'descriptionModule': {'briefSummary': 'Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.', 'detailedDescription': 'Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.\n\nDuring follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.\n\nHealth Related Quality of Life (HRQL) has been regularly checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed achalasia\n* Age 18-80 years\n* Informed consent\n\nExclusion Criteria:\n\n* Previous treatment for achalasia.\n* Stage IV achalasia.\n* Unwillingness to participate.'}, 'identificationModule': {'nctId': 'NCT02086669', 'briefTitle': 'Pneumatic Dilatation or Surgical Myotomy for Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up', 'orgStudyIdInfo': {'id': 'S500-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pneumatic dilatation', 'description': 'Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.', 'interventionNames': ['Procedure: Pneumatic dilatation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical myotomy', 'description': 'Laparoscopic myotomy and subsequent follow up.', 'interventionNames': ['Procedure: Laparoscopic myotomy']}], 'interventions': [{'name': 'Pneumatic dilatation', 'type': 'PROCEDURE', 'armGroupLabels': ['Pneumatic dilatation']}, {'name': 'Laparoscopic myotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Surgical myotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41132', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Lars Lundell, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Lundell', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}