Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT05851534
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Stepped-wedge cluster randomized superiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2575}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to functional recovery', 'timeFrame': 'On average 6-10 days', 'description': 'Functional recovery is achieved when all of the following five criteria are met:\n\na) restored level of mobility at the preoperative level, b) sufficient pain control with oral medication alone, c) ability to maintain at least 50% daily required energy intake, d) no intravenous fluid administration, and e) no clinical signs of infection.'}], 'secondaryOutcomes': [{'measure': 'Comprehensive Complication Index (CCI)', 'timeFrame': '30 days postoperative', 'description': 'The CCI is calculated as the sum of all complications that are weighted for their severity, with a range from 0 to 100, whereby a higher score indicates presence of more complications and/or more severe complications.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'On average 2 weeks postoperative', 'description': 'Length of hospital stay of the primary admission, measured in days'}, {'measure': 'Readmissions', 'timeFrame': '30 days after discharge of primary admission', 'description': 'Readmissions within 30 days after discharge'}, {'measure': 'Postoperative complications', 'timeFrame': 'During primary admission, on average 14 weeks postoperative', 'description': 'Any postoperative complication'}, {'measure': 'Incremental cost-effectiveness ratio (ICER)', 'timeFrame': '1 year postoperative', 'description': 'The difference in costs between standard care and best practice care divided by the difference in health benefits, measured in quality-adjusted life years (QALYs).'}, {'measure': 'Evaluation of health status', 'timeFrame': 'At baseline, 3 months and 12 months postoperative', 'description': 'Reported health status measured with questionnaire EQ-5D-5L'}, {'measure': 'Evaluation of quality of life for cancer patients', 'timeFrame': 'At baseline, 3 months and 12 months postoperative', 'description': 'Reported quality of life measured with questionnaire EORTC QLQ-C30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Pancreas', 'Preoperative optimisation'], 'conditions': ['Prehabilitation', 'Pancreas Cancer', 'Surgery', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The goal of this stepped-wedge randomized controlled trial is to investigate whether implementation of a best practice program for preoperative optimisation (prehabilitation program) with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors in patients with (suspected) pancreatic cancer will improve outcome. The main questions it will aim to answer are:\n\n1. Does a prehabilitation program improve the time to functional recovery after pancreatic surgery?\n2. Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?', 'detailedDescription': "Background In the past, little attention has been given in the daily practice to the patient's condition before an operation. Recent studies have shown the benefit of preoperative optimisation programs. However, these studies consisted only of smaller studies and were mainly performed in patients who underwent colorectal surgery. Although promising, unfortunately, strong evidence to support the contribution of prehabilitation to optimize the functional outcome after surgery is still lacking and consequently it is not included in the Dutch basic health insurance package.\n\nObjective To investigate whether implementation of a best practice program for preoperative optimisation of patients with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors (low (aerobic) fitness level, malnutrition, low psychological resilience, comorbidities (iron deficiency (anaemia), impaired glucose control and frailty), and intoxications (alcohol and smoking behaviour)) will improve the time to functional recovery.\n\nStudy design A nationwide stepped-wedge cluster randomized trial. In this design all participating centres will cross over from current practice to the best practice program, in a randomised order. At the end of the study, all centres will have implemented the best practice program.\n\nStudy population 13 centres performing major pancreatic surgery in the Netherlands collaborating within the Dutch Pancreatic Cancer Group (DPCG).\n\nIntervention Preoperative screening of all patients scheduled for pancreatic resection on (aerobic) fitness level, malnutrition risk, psychological resilience, haemoglobin, iron and HbA1c concentration, frailty, and alcohol and smoking behaviour. All patients are provided with a patient-tailored, multimodal prehabilitation program, in which these potentially (partly) modifiable factors are preoperatively addressed. This program is based on findings in previous screening and prehabilitation programs, a national inventory of current preoperative care protocols and expert opinion. Consensus upon this program was reached with pancreatic surgeons from all centres of the DPCG. The final program was critically reviewed by the advisory committee of internationally respected experts in the field of prehabilitation and pancreatology.\n\nComparison Preoperative care according to current practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are planned for a curative treatment with or without neoadjuvant treatment and elective pancreatic resection in one of the centres of the Dutch Pancreatic Cancer Group (i.e. all centres performing major pancreatic surgery)\n\nExclusion Criteria:\n\n* age \\< 18 years\n* acute pancreatic resections (resection scheduled within two weeks)'}, 'identificationModule': {'nctId': 'NCT05851534', 'acronym': 'PROMISE-P', 'briefTitle': 'Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection', 'orgStudyIdInfo': {'id': '2023-3607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Receiving standard preoperative care'}, {'type': 'EXPERIMENTAL', 'label': 'Best practice program', 'description': 'Implementation of best practice preoperative optimisation program', 'interventionNames': ['Behavioral: Preoperative optimisation program']}], 'interventions': [{'name': 'Preoperative optimisation program', 'type': 'BEHAVIORAL', 'description': 'Preoperative screening of all patients scheduled for pancreatic resection on (aerobic) fitness level, malnutrition risk, psychological resilience, haemoglobin, iron and HbA1c concentration, frailty, and alcohol and smoking behaviour. All patients are provided with a patient-tailored, multimodal prehabilitation program, in which these potentially (partly) modifiable factors are preoperatively addressed', 'armGroupLabels': ['Best practice program']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Koop Bosscha, MD PhD', 'role': 'CONTACT'}], 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marc Besselink, MD PhD', 'role': 'CONTACT'}], 'facility': 'Amsterdam University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Tom Karsten, MD PhD', 'role': 'CONTACT'}], 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jennifer Schreinemakers, MD PhD', 'role': 'CONTACT'}], 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ignace de Hingh, MD PhD', 'role': 'CONTACT'}], 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Enschede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Daan Lips, MD PhD', 'role': 'CONTACT'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joost Klaase, MD PhD', 'role': 'CONTACT'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leeuwarden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Eric Manusama, MD PhD', 'role': 'CONTACT'}], 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sven Mieog, MD PhD', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202AZ', 'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marcel den Dulk, MD PhD', 'role': 'CONTACT'}], 'facility': 'Maatricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Kees van Laarhoven, MD PhD', 'role': 'CONTACT'}], 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bas Groot Koerkamp, MD PhD', 'role': 'CONTACT'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hjalmar van Santvoort, MD PhD', 'role': 'CONTACT'}], 'facility': 'RAKU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Marcel den Dulk, MD PhD', 'role': 'CONTACT', 'email': 'marcel.den.dulk@mumc.nl', 'phone': '+3143 3875492'}, {'name': 'Heleen Driessens, MD', 'role': 'CONTACT', 'email': 'h.driessens@umcg.nl', 'phone': '+316 83058108'}], 'overallOfficials': [{'name': 'Marcel den Dulk, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center/ University Maastricht'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial will be shared, after deidentification upon reasonable request.', 'accessCriteria': 'Data will be available upon request. Request should be directed to marcel.den.dulk@mumc.nl.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rising Tide Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}