Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:05 PM
Study NCT ID:
NCT07368218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Transmesocolic Versus Retromesenteric Reconstruction in Cephalic Duodenopancreatectomy (FAST Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018589', 'term': 'Gastroparesis'}], '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': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed Gastric Emptying', 'timeFrame': 'From first postoperative day to 30 days', 'description': 'Delayed gastric emptying according to ISGPS 2007 definition: Grade A (nasogastric tube \\>3 days or reinsertion between days 4-7 + vomiting); Grade B (tube \\>7 days or reinsertion after day 7 + vomiting); Grade C (impossibility of oral tolerance after day 14)'}], 'secondaryOutcomes': [{'measure': 'Postoperative morbility', 'timeFrame': 'Form first postoperative day to day 30', 'description': 'Postoperative morbidity at 90 days according to Clavien-Dindo classification (≥ Grade I)'}, {'measure': 'Pancreatic fistula', 'timeFrame': 'From first postoperative day to day 30', 'description': 'Pancreatic fistula according to ISGPF 2016 definition: Grade A (drainage amylase \\>3x normal on day 3 without clinical impact); Grade B (requiring management change); Grade C (reintervention or death)'}, {'measure': 'Mortality', 'timeFrame': 'From first postoperative day to day 90', 'description': '30- and 90-day mortality (any cause)'}, {'measure': 'Hospital stay', 'timeFrame': 'From first postoperative day to hospital discharge up to 15 weeks', 'description': 'Postoperative hospital stay days (from surgery to hospital discharge)'}, {'measure': 'Operative time', 'timeFrame': 'Periprocedural time, an average time of 300-400 minutes', 'description': 'Total operative time (minutes)'}, {'measure': 'Proportion of patients with NLR index ≥5', 'timeFrame': 'From the first postoperative day to one year follow-up', 'description': 'First, a preoperative NLR index determination from the preoperative blood count.\n\nProportion of patients with NLR cut-off point ≥5, which is associated with lower overall survival and recurrence-free survival in patients undergoing pancreatic resection.'}, {'measure': 'Proportion of patients with CA19.9 >37 U/ml', 'timeFrame': 'From the first postoperative day to one year follow-up', 'description': 'First, a preoperative CA19.9 measurement from preoperative laboratory tests. Determination of the proportion of patients with CA 19.9 cut-off point \\>37 U/ml, as it is considered elevated according to the standard reference range.'}, {'measure': 'Cytokines in serum', 'timeFrame': 'From the first postoperative day to day 90', 'description': '* Cytokine concentration in serum: continuous variable measured at 24 hours and day 5 post-surgery in a subsample of 30 patients.\n* Detection panel: 2000 inflammatory biomarkers using high-sensitivity semi-quantitative Raybiotech L-series arrays with densitometric reading'}, {'measure': 'Cytokines in abdominal drainage', 'timeFrame': 'From the first postoperative day to day 90', 'description': '* Cytokine concentration in drainage fluid: continuous variable measured at 24 hours and day 5 post-surgery in a subsample of 30 patients.\n* Detection panel: 2000 inflammatory biomarkers using high-sensitivity semi-quantitative Raybiotech L-series arrays with densitometric reading'}, {'measure': 'Cytokines and complications correlation', 'timeFrame': 'From the first postoperative day to day 90', 'description': 'Exploratory analysis of the association between cytokine levels and the appearance of complications during the first 90 days.'}, {'measure': 'Recurrence', 'timeFrame': 'From the first postoperative day to one year follow-up', 'description': '\\- Recurrence of malignant pathology: Defined as the appearance of local, regional, or distant disease documented by imaging techniques (CT/MRI) or histopathological confirmation.'}, {'measure': 'Time to recurrence', 'timeFrame': 'From the first postoperative day to one year follow-up', 'description': '\\- Time to recurrence: Time elapsed from surgery to detection of recurrence (months).'}, {'measure': 'Complications-recurrence correlation', 'timeFrame': 'From the first postoperative day to one year follow-up', 'description': 'Association analysis between the presence of complications (Clavien-Dindo ≥ II) and early recurrence (≤12 months).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['duodenopancreatectomy', 'Pancreatic cancer', 'Delayed Gastric emptying'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the incidence of delayed gastric emptying (ISGPS 2007 criteria) between patients undergoing retromesenteric versus transmesocolic reconstruction after pancreaticoduodenectomy. Secondary objectives include evaluating overall postoperative morbidity (Clavien-Dindo ≥ Grade I) at 90 days, postoperative pancreatic fistula according to ISGPF criteria, 30- and 90-day mortality, differences in operative time and blood loss, hospital stay duration, exploratory analysis of inflammatory biomarkers in serum and drainage fluid, psychological impact using SCL-90-R scale, and postoperative quality of life using EORTC QLQ-C30 scale.\n\nMethods: Randomized, controlled, single-center superiority clinical trial with 1:1 allocation. One hundred twenty-four patients candidates for duodenopancreatectomy due to pancreatic pathology will be randomized using balanced blocks to transmesocolic (control) or retromesenteric (study) reconstruction. Randomization will be revealed after completing the resection phase. Primary intention-to-treat analysis will estimate relative risk with 95% CI for dichotomous variables, Kaplan-Meier survival analysis with log-rank test, and linear mixed models for repeated measures in quality of life outcomes. Follow-up will be 90 days for the primary endpoint, extending to 12 months for secondary objectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Candidates for cephalic duodenopancreatectomy due to pancreatic pathology\n* Ability to complete follow-up questionnaires\n\nExclusion Criteria:\n\n* Emergency surgery\n* Participation in another clinical trial\n* Pregnancy or lactation\n* Severe psychiatric disorder that prevents follow-up\n* Inability to understand the information and sign study consent'}, 'identificationModule': {'nctId': 'NCT07368218', 'acronym': 'FAST', 'briefTitle': 'Comparison of Transmesocolic Versus Retromesenteric Reconstruction in Cephalic Duodenopancreatectomy (FAST Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Randomized Clinical Trial on Morbidity, Psychological Impact, and Changes in Biomarker Concentration During the Perioperative Period Comparing Transmesocolic Versus Retromesenteric Reconstruction in Cephalic Duodenopancreatectomy (FAST Trial)', 'orgStudyIdInfo': {'id': 'HUB-CIR-FAST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retromesenteric reconstruction', 'interventionNames': ['Procedure: Retromesenteric reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transmesocolic reconstruction', 'interventionNames': ['Procedure: Transmesocolic reconstruction']}], 'interventions': [{'name': 'Retromesenteric reconstruction', 'type': 'PROCEDURE', 'description': 'Perform a retromesenteric reconstruction after pancreaticoduodenectomy', 'armGroupLabels': ['Retromesenteric reconstruction']}, {'name': 'Transmesocolic reconstruction', 'type': 'PROCEDURE', 'description': 'Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy', 'armGroupLabels': ['Transmesocolic reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Spain', 'country': 'Spain', 'contacts': [{'name': 'Juli Busquets Barenys, Md, PhD', 'role': 'CONTACT', 'email': 'jbusquets@bellvitgehospital.cat', 'phone': '93 260 75 00'}], 'facility': 'Hopital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Juli Busquets Barenys, Md, PhD', 'role': 'CONTACT', 'email': 'jbusquets@bellvitgehospital.cat', 'phone': '93 260 75 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pancreatic Surgery Unit', 'investigatorFullName': 'BUSQUETS, JULI', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}