Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-27 @ 2:22 PM
Study NCT ID:
NCT03566056
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2018-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Recovery Outcomes After Standardized Fast-track Whipples Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)', 'timeFrame': '6 am on the day after surgery', 'description': 'Number of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure \\>65 mmHg, the first morning after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Cancer']}, 'descriptionModule': {'briefSummary': 'Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.\n\nNevertheless, no studies have in detail described the acute (\\<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..\n\nThe purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included is chosen from all the patients in the surgery ward when they have undergone the Whipples procedure and furthermore meet the criteria listed above.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* the patient has undergone the Whipple procedure\n* The patient is over 18 years ol\n* The patient has signed a consent statement from the postoperative therapy ward\n\nExclusion Criteria:\n\n* The patient did not receive 125 mg of methylprednisolone prior to the operation\n* The patient did only undergo pancreatectomy\n* The patient wasn't given epidural anesthesia\n* the patient was given anesthesia through a mask"}, 'identificationModule': {'nctId': 'NCT03566056', 'briefTitle': 'Early Recovery Outcomes After Standardized Fast-track Whipples Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Early Recovery Outcomes After Standardized Fast-track Whipples Procedure', 'orgStudyIdInfo': {'id': 'RH-2016-304-potawhipple'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Complications to Whipples procedure', 'type': 'OTHER', 'description': 'Patients undergoing the Whipple procedure often tend to have a lot of complications. This study aims to investigate what complications these patients experience'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This has jet not been discussed within the group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eske Kvanner Aasvang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, Associate professor', 'investigatorFullName': 'Eske Kvanner Aasvang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}