Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05641233
Status:
UNKNOWN
Last Update Posted:
2022-12-07
First Post:
2022-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010185', 'term': 'Pancreatic Fistula'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - CTCAE grade 3-4-5 complications related to the intervention', 'timeFrame': 'Up to 30 days after surgery'}, {'measure': 'Hardness of pancreas texture, determined by Durometer measurement', 'timeFrame': 'Histopathological assesment of tissue after surgery', 'description': 'Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C', 'timeFrame': 'Up to 30 days after operation', 'description': 'Defined by the ISGPS guideline (2016)'}, {'measure': 'Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon', 'timeFrame': 'Assesment during surgery', 'description': 'Texture is scaled as soft/intermediate/hard'}, {'measure': 'Macroscopic tissue assessment, determined by the pathologist', 'timeFrame': 'Histopathological assesment after surgery', 'description': 'Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue'}, {'measure': 'Surgery related postoperative complications defined according to the Clavien-Dindo classification', 'timeFrame': 'Up to 30 days after surgery'}, {'measure': 'Overall complications', 'timeFrame': 'Up to 30 days after surgery'}, {'measure': 'Readmission rate', 'timeFrame': 'Postoperative period'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Days'}, {'measure': '30-day mortality and in-hospital mortality', 'timeFrame': 'Up to 30 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post operative pancreatic fistula', 'Stereotactic radiotherapy', 'Pancreatic fibrosis', 'Pancreatoduodenectomy'], 'conditions': ['Neuroendocrine Carcinoma of Pancreas', 'Duodenum Carcinoma', 'Pancreas Neoplasm', 'Distal Cholangiocarcinoma', 'GIST', 'Pancreas Fibrosis', 'Pancreatic Fistula']}, 'referencesModule': {'references': [{'pmid': '39317507', 'type': 'DERIVED', 'citation': 'Suurmeijer JA, Wismans LV, Hendriks TE, Bruynzeel AM, Nuyttens JJ, Intven MPW, van Driel LMJW, Groot Koerkamp B, Busch OR, Stoker JJ, Verheij J, Farina A, Doukas M, de Hingh IHJ, Lips DJ, van der Harst E, van Tienhoven G, Besselink MG, van Eijck CHJ; Dutch Pancreatic Cancer Group. Feasibility, safety and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the risk of pancreatic fistula after high-risk pancreatoduodenectomy (FIBROPANC): protocol for a multicentre, single-arm trial. BMJ Open. 2024 Sep 24;14(9):e087193. doi: 10.1136/bmjopen-2024-087193.'}]}, 'descriptionModule': {'briefSummary': 'The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (\\>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.\n* Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).\n* WHO-ECOG performance status 0,1 or 2.\n* Ability to undergo stereotactic radiotherapy and surgery.\n* Age ≥ 18 years.\n* Good understanding of the oral and written patient information provided.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.\n* Patients with (a history of) chronic pancreatitis'}, 'identificationModule': {'nctId': 'NCT05641233', 'acronym': 'FIBROPANC-1', 'briefTitle': 'Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study', 'orgStudyIdInfo': {'id': 'NL72913.018.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}], 'interventions': [{'name': 'Stereotactic radiotherapy', 'type': 'RADIATION', 'description': 'Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Tessa Hendriks', 'role': 'CONTACT', 'email': 't.e.hendriks@amsterdamumc.nl'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Leonoor Wismans', 'role': 'CONTACT', 'email': 'l.wismans@erasmusmc.nl'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Leonoor Wismans', 'role': 'CONTACT', 'email': 'l.wismans@erasmusmc.nl', 'phone': '010-703 38 54'}, {'name': 'Tessa Hendriks', 'role': 'CONTACT', 'email': 't.e.hendriks@amsterdamumc.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr. Casper H.J. van Eijck', 'investigatorFullName': 'Casper H.J. van Eijck', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}