Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT05567094
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2022-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients, surgeons, anesthetists, data collectors, and outcome assessors are all blinded. Only the data manager and the specific study coordinator are unblinded to the group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-10-01', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Comprehensive Complication Index (CCI)', 'timeFrame': 'Within 30 days after the operation', 'description': 'The Comprehensive Complication Index (CCI) score within 30 days after the operation.\n\nThe CCI takes into account all cumulative complications and receives values between 0 and 100. The weight of complication (wC) of the CCI is based on the established Clavien-Dindo classification.'}], 'secondaryOutcomes': [{'measure': 'The incidence of major complications (Clavien-Dindo≥3)', 'timeFrame': '30 days'}, {'measure': 'The incidence of postoperative pancreatic fistula (ISGPS classification)', 'timeFrame': '30 days'}, {'measure': 'The incidence of postpancreatectomy acute pancreatitis (ISGPS classification)', 'timeFrame': '30 days'}, {'measure': 'The incidence of infection (including wound infection and intra-abdominal abscess)', 'timeFrame': '30 days'}, {'measure': 'Postoperative length of stay', 'timeFrame': '1 day of discharge'}, {'measure': 'The incidence of relaparotomy', 'timeFrame': '30 days'}, {'measure': 'Mortality', 'timeFrame': '30 days'}, {'measure': 'Mortality', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreaticoduodenectomy', 'Dexamethasone', 'Postoperative complications', 'Double-blind', 'Pragmatic', 'Superiority trial'], 'conditions': ['Pancreaticoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '35848748', 'type': 'BACKGROUND', 'citation': 'Chen H, Wang C, Shen Z, Wang W, Weng Y, Ying X, Deng X, Shen B. Postpancreatectomy Acute Pancreatitis After Pancreaticoduodenectomy: A Distinct Clinical Entity. Ann Surg. 2023 Aug 1;278(2):e278-e283. doi: 10.1097/SLA.0000000000005605. Epub 2022 Jul 18.'}, {'pmid': '28420629', 'type': 'BACKGROUND', 'citation': 'DREAMS Trial Collaborators and West Midlands Research Collaborative. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). BMJ. 2017 Apr 18;357:j1455. doi: 10.1136/bmj.j1455.'}, {'pmid': '33951362', 'type': 'BACKGROUND', 'citation': "Corcoran TB, Myles PS, Forbes AB, Cheng AC, Bach LA, O'Loughlin E, Leslie K, Chan MTV, Story D, Short TG, Martin C, Coutts P, Ho KM; PADDI Investigators; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australasian Society for Infectious Diseases Clinical Research Network. Dexamethasone and Surgical-Site Infection. N Engl J Med. 2021 May 6;384(18):1731-1741. doi: 10.1056/NEJMoa2028982."}, {'pmid': '27429037', 'type': 'BACKGROUND', 'citation': 'Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.'}, {'pmid': '34078591', 'type': 'BACKGROUND', 'citation': 'Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.'}, {'pmid': '37660052', 'type': 'DERIVED', 'citation': 'Chen H, Wang Y, Wang C, Lu X, Li Y, Sun B, Jiang K, Qiu Y, Chen R, Cao L, Chen S, Luo Y, Shen B. The effect of perioperative of dexamethasone on postoperative complications after pancreaticoduodenectomy (PANDEX): a study protocol for a pragmatic multicenter randomized controlled trial. Trials. 2023 Sep 2;24(1):569. doi: 10.1186/s13063-023-07571-y.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.', 'detailedDescription': 'This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients ≥18 years of age;\n2. An indication for elective PD surgery;\n3. Patients understand the nature of this trial and are willing to comply;\n4. Patients are able to provide written informed consent;\n\nExclusion Criteria:\n\n1. Current or recent (within preceding 1 month) systemic use of glucocorticoids;\n2. Distant metastases including peritoneal carcinomatosis, liver metastases, distant lymph node metastases, and involvement of other organs;\n3. Patients may undergo left, central, or total pancreatectomy other than PD;\n4. Palliative surgery；\n5. Patients with high operative risk, as defined by the American Society of Anesthesiologists (ASA), with a score ≥ 4;\n6. Synchronous malignancy in other organs or second cancer requiring resection during the same procedure;\n7. Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT05567094', 'acronym': 'PANDEX', 'briefTitle': 'The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'PANDEX-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline placebo', 'description': 'Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'interventionNames': ['Drug: Saline placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Saline placebo', 'type': 'DRUG', 'description': 'Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'armGroupLabels': ['Saline placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BAIYONG SHEN', 'investigatorAffiliation': 'Ruijin Hospital'}}}}