Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 8:23 PM
Study NCT ID:
NCT04870268
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Phase Acute Pancreatitis: a Tailored Step-up Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-31', 'size': 226734, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-23T06:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'targetDuration': '22 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction assessed by the SF-36 (36-Item Short Form Survey)', 'timeFrame': '1 year', 'description': 'English Standard Short Form 36 (SF-36) questionnaire is used to evaluate the general quality of life. The SF-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. The eight scaled scores are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pancreatitis', 'walled-off necrosis', 'surgical treatment', 'quality of life'], 'conditions': ['Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '35639137', 'type': 'DERIVED', 'citation': 'Di Candio G, Guadagni S, Furbetta N, Gianardi D, Palmeri M, Di Franco G, Bianchini M, Gambaccini D, Marciano E, Cervelli R, Marchi S, Morelli L. A "tailored" interventional and surgical management for moderate to critical acute pancreatitis in late phase: a cohort study. Langenbecks Arch Surg. 2022 Nov;407(7):2833-2841. doi: 10.1007/s00423-022-02557-x. Epub 2022 May 31.'}]}, 'descriptionModule': {'briefSummary': 'Several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (AP) in its late phase. The ongoing debate on these options, together with the scarcity of reported mid-term follow-up information in the Literature, prompted the investigators to conduct a review of our surgical experience, focused on those issues. The investigators reviewed retrospectively all the patients treated for moderate-to-critical AP according to Determinant-Based Classification (DBC), in the last nine years. Patients treated conservatively or operated within 4 weeks of the onset of the pancreatitis were excluded. All the included patients were managed following a "tailored" step-up approach, and divided into four groups, according to the first interventional procedure performed: percutaneous drainage (PD), endoscopic approach (END), internal derivation (INT), and necrosectomy (NE). In-hospital and mid-term follow-up variables, including a quality-of-life assessment, were analyzed and compared.', 'detailedDescription': 'The following variables were evaluated: sex, age, severity of inflammation according to the DBC classification, PA etiology, CT scan severity index according to Balthazar criteria , clinical prognostic score using bedside index of severity of acute pancreatitis (BISAP) score.\n\nTotal length of hospitalization, operative management, necrosis cultures, total and post-interventional Intensive Unit Care (ICU) were also recorded and analyzed together with the in-hospital morbidity, mortality and re-admissions.\n\nPatients were checked after discharge within 14 days and followed monthly as outpatients by gastroenterologists. A CT scan was performed within 4 months, or before in case of recurrent symptoms. During the follow-up, the English Standard Short Form 36 (SF-36) questionnaire was used to evaluate the general quality of life at three and six months, one and two years. The SF-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. At the six-month follow-up, the patients also completed a specific questionnaire about the pancreatic function. In particular, the total score takes in consideration abdominal pain using visual analogue pain score, diarrhea, unintentional weight loss, new onset of diabetes and use of enzyme supplementation. The score ranges between zero to five (all symptoms present). The work has been reported in line with the STROCSS criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort sample was divided into four groups, according to the first type of the interventional or surgical management performed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients treated at our referral Center for moderate to critical AP, as classified by Determinant-Based Classification of Acute Pancreatitis Severity\n\nExclusion Criteria:\n\n* patients who had undergone conservative treatment,\n* patients who has been operated within 4 weeks (early phase)'}, 'identificationModule': {'nctId': 'NCT04870268', 'acronym': 'TSA', 'briefTitle': 'Late Phase Acute Pancreatitis: a Tailored Step-up Approach', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'A Tailored Step-up Approach for Moderate to Critical Acute Pancreatitis in the Late Phase: a Cohort Study', 'orgStudyIdInfo': {'id': 'example-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD group', 'description': 'percutaneous drainage group', 'interventionNames': ['Procedure: percutaneous drainage']}, {'label': 'END group', 'description': 'endoscopic approach group', 'interventionNames': ['Procedure: endoscopic approach']}, {'label': 'INT group', 'description': 'surgical internal derivation of WON group', 'interventionNames': ['Procedure: surgical internal derivation of WON']}, {'label': 'NE group', 'description': 'surgical necrosectomy group', 'interventionNames': ['Procedure: surgical necrosectomy']}], 'interventions': [{'name': 'percutaneous drainage', 'type': 'PROCEDURE', 'armGroupLabels': ['PD group']}, {'name': 'endoscopic approach', 'type': 'PROCEDURE', 'armGroupLabels': ['END group']}, {'name': 'surgical internal derivation of WON', 'type': 'PROCEDURE', 'armGroupLabels': ['INT group']}, {'name': 'surgical necrosectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['NE group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Simone guadagni', 'investigatorAffiliation': 'University of Pisa'}}}}