Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT02845258
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010192', 'term': 'Pancreatic Pseudocyst'}], 'ancestors': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069322', 'term': 'Self Expandable Metallic Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Pancreatic pseudocyst fluid aspirate for culture and biochemical analysis. No DNA analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short time complication rate', 'timeFrame': 'Uo to 48 hours', 'description': 'The number of EUS-procedure-related complications such as bleeding, infection and death.'}, {'measure': 'Repeated drainage frequency', 'timeFrame': 'Up to 3 months', 'description': 'A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded.'}], 'secondaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': 'Up to 30 days', 'description': 'The number of days spent in hospital post-EUS-drainage'}, {'measure': 'Long time complication rate', 'timeFrame': 'Up to 6 months', 'description': 'Infections and other complications related to the non-complete drainage of the pseudocyst after discharge from the hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Pseudocyst', 'Drainage']}, 'descriptionModule': {'briefSummary': 'Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.\n\nThis study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.', 'detailedDescription': 'Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients \\>18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\>18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage\n\nExclusion Criteria:\n\n* Patients unwilling to participate or unable to understand or sign the informed consent\n* Patients with no need for pseudocyst drainage as assessed by the endosonographer'}, 'identificationModule': {'nctId': 'NCT02845258', 'briefTitle': 'Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage', 'orgStudyIdInfo': {'id': 'Dnr 573-09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)', 'type': 'PROCEDURE', 'description': 'Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS):\n\nThis procedure is to be regarded as a clinical routine procedure since a couple of years back. The type of stent (material? length? thickness?), the cyst appearance (large? infected? cyst wall thickness?) and the type of access (transgastric? transduodenal?) may however vary from patient to patient.\n\nIn this study we perform EUS-drainage using different types of equipment on a wide range of pancreatic pseudocysts of different appearance and character. All procedures are performed as recommended. The very aim of the study is to investigate which technique and Equipment is to be preferred in different scenarios.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-413 45', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per Hedenström, MD', 'role': 'CONTACT', 'email': 'per.hedenstrom@vgregion.se', 'phone': '+46 703 288291'}], 'facility': 'Endoscopy Department GEA, Sahlgrenska university Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Per Hedenström, MD', 'role': 'CONTACT', 'email': 'per.hedenstrom@vgregion.se', 'phone': '+46 703 288291'}, {'name': 'Riadh Sadik, Ass prof', 'role': 'CONTACT', 'email': 'riadh.sadik@vgregion.se', 'phone': '+46 733 641355'}], 'overallOfficials': [{'name': 'Riadh Sadik, Ass Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahlgrenska University Hospital, Gothenburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Per Hedenström', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}