Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03570502
Status:
UNKNOWN
Last Update Posted:
2018-06-27
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of POPF in the Resection of the Left Pancreas With RFAT
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-15', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)', 'timeFrame': '1 month', 'description': '"Grade A postoperative pancreatic fistula" is now redefined and called a "biochemical leak," because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place \\>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.'}], 'secondaryOutcomes': [{'measure': 'Sex', 'timeFrame': 'Inclusion of the patient in the study', 'description': 'Gender or the patient (Male/Female)'}, {'measure': 'Age', 'timeFrame': 'Inclusion of the patient in the study', 'description': 'Age of the patient (expressed in years) at the moment of the intervention'}, {'measure': 'Consistency of the pancreas', 'timeFrame': 'Inclusion of the patient in the study', 'description': 'It can be defined as "normal", "soft" or "fibrotic"'}, {'measure': 'Level of jaundice', 'timeFrame': 'At the moment of the intervention and during the first week of postoperative period', 'description': 'Bilirubin level at the moment of the intervention and during the first week of postoperative period'}, {'measure': 'Type of surgical procedure', 'timeFrame': 'Inclusion of the patient in the study', 'description': 'Enucleation, central pancreatectomy or distal pancreatectomy'}, {'measure': 'Laparoscopic or open surgery', 'timeFrame': 'Inclusion of the patient in the study', 'description': 'Laparoscopic or open surgery'}, {'measure': 'Total bleeding', 'timeFrame': 'During the intervention', 'description': 'Measured during the procedure'}, {'measure': 'Size of the pancreatic duct', 'timeFrame': 'CT scan prior to surgery', 'description': 'Size of the main pancreatic duct expressed in mm, measured on the last CT before the procedure'}, {'measure': 'Type of tumour', 'timeFrame': 'Diagnosis', 'description': 'Serous cystadenoma Acinar cystadenoma Ductal adenocarcinoma Acinar cell carcinoma Cystadenocarcinoma of acinar cells Intraductal papillary mucinous neoplasia associated with invasive carcinoma Mixed carcinoma (ductal-neuroendocrine or acinar-neuroendocrine) Cystic mucinous neoplasia associated with invasive carcinoma Pancreatoblastoma Serous cystadenocarcinoma Pseudopapillary-solid neoplasia'}, {'measure': 'Postoperative follow-up', 'timeFrame': '1 year', 'description': 'Months of follow-up since the pancreatic procedure'}, {'measure': 'Type of the postoperative complication', 'timeFrame': '1 month', 'description': 'Description of the type of complication'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Prior the surgery and during the PO follow-up (1 and 6 months)', 'description': 'Measured such as: BMI in kg/m\\^2'}, {'measure': 'Diabetes', 'timeFrame': 'Before the precedure and during the PO follow-up (1 and 6 months)', 'description': 'Does the patient has diabetes before or after the precedure?'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Neoplasm', 'Pancreas Cancer', 'Pancreatic Adenocarcinoma', 'Benign Pancreas Tumor']}, 'referencesModule': {'references': [{'pmid': '26821683', 'type': 'BACKGROUND', 'citation': 'Burdio F, Dorcaratto D, Hernandez L, Andaluz A, Moll X, Quesada R, Poves I, Grande L, Caceres M, Berjano E. Radiofrequency-induced heating versus mechanical stapler for pancreatic stump closure: in vivo comparative study. Int J Hyperthermia. 2016 May;32(3):272-80. doi: 10.3109/02656736.2015.1136845. Epub 2016 Jan 29.'}, {'pmid': '27865280', 'type': 'BACKGROUND', 'citation': 'Malleo G, Vollmer CM Jr. Postpancreatectomy Complications and Management. Surg Clin North Am. 2016 Dec;96(6):1313-1336. doi: 10.1016/j.suc.2016.07.013.'}, {'pmid': '28857813', 'type': 'BACKGROUND', 'citation': 'Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491.'}, {'pmid': '15585382', 'type': 'BACKGROUND', 'citation': 'Lin JW, Cameron JL, Yeo CJ, Riall TS, Lillemoe KD. Risk factors and outcomes in postpancreaticoduodenectomy pancreaticocutaneous fistula. J Gastrointest Surg. 2004 Dec;8(8):951-9. doi: 10.1016/j.gassur.2004.09.044.'}, {'pmid': '15832417', 'type': 'BACKGROUND', 'citation': 'Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.'}, {'pmid': '24977335', 'type': 'BACKGROUND', 'citation': 'Quesada R, Burdio F, Iglesias M, Dorcaratto D, Caceres M, Andaluz A, Poves I, Castiella T, Sanchez P, Berjano E, Grande L. Radiofrequency pancreatic ablation and section of the main pancreatic duct does not lead to necrotizing pancreatitis. Pancreas. 2014 Aug;43(6):931-7. doi: 10.1097/MPA.0000000000000156.'}, {'pmid': '23584822', 'type': 'BACKGROUND', 'citation': 'Dorcaratto D, Burdio F, Fondevila D, Andaluz A, Quesada R, Poves I, Caceres M, Mayol X, Berjano E, Grande L. Radiofrequency is a secure and effective method for pancreatic transection in laparoscopic distal pancreatectomy: results of a randomized, controlled trial in an experimental model. Surg Endosc. 2013 Oct;27(10):3710-9. doi: 10.1007/s00464-013-2952-1. Epub 2013 Apr 13.'}, {'pmid': '26639388', 'type': 'BACKGROUND', 'citation': 'Quesada R, Andaluz A, Caceres M, Moll X, Iglesias M, Dorcaratto D, Poves I, Berjano E, Grande L, Burdio F. Long-term evolution of acinar-to-ductal metaplasia and beta-cell mass after radiofrequency-assisted transection of the pancreas in a controlled large animal model. Pancreatology. 2016 Jan-Feb;16(1):38-43. doi: 10.1016/j.pan.2015.10.014. Epub 2015 Nov 18.'}, {'pmid': '21529927', 'type': 'BACKGROUND', 'citation': 'Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.'}, {'pmid': '16003309', 'type': 'BACKGROUND', 'citation': 'Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.'}, {'pmid': '28040257', 'type': 'BACKGROUND', 'citation': 'Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of the Radiofrequency assisted transection on the rate of postoperative pancreatic fistula (POPF) after performing distal pancreatectomies, central pancreatectomies and pancreatic enucleation', 'detailedDescription': 'Among the different methods for sealing the remaining pancreas, resection and sealing devices assisted by radiofrequency energy (RF) have been used, both in experimental studies and in clinical trials, in order to try to reduce the POPF rate. One of these devices is the Coolinside®, which is approved for this indication and is currently used in selected cases, at the Hospital del Mar, among other centers.\n\nAlthough there are several published studies based on similar technology, the existing publications on the use of Coolinside® in the pancreas have been made in rat and pig animal models. In particular, the most recent study published by Dorcaratto et al. compares the Coolinside device vs. the mechanical stapler in porcine model when performing distal pancreatectomies. The results suggest that the Coolinside device was more efficient in the control of the POPF than the stapler with a POPF index of 12% vs. 36%.\n\nTherefore, this study aims to obtain more clinical evidence about the use of Coolinside in pancreatic resections within a clinical context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with benign and malignant pancreatic tumours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with benign or malignant lesions of the pancreas\n* Subjected to distal, central pancreatectomy or enucleations of the left pancreas\n* Patients ASA (American Society of Anesthesiologists I-III\n* Open or laparoscopic approach.\n\nExclusion Criteria:\n\n* ASA ≥IV patients\n* Patients with limitrophic or neuroendocrine lesions'}, 'identificationModule': {'nctId': 'NCT03570502', 'acronym': 'RFATPancreas', 'briefTitle': 'Incidence of POPF in the Resection of the Left Pancreas With RFAT', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Mar'}, 'officialTitle': 'Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)', 'orgStudyIdInfo': {'id': '2017/7697/I'}}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignasi Poves', 'role': 'CONTACT', 'email': 'ipoves@parcdesalutmar.cat', 'phone': '93 248 32 07'}, {'name': 'Ignasi Poves, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fernando Burdío, PhD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dimitri Dorcaratto, PhD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Ignasi Poves, Phd, MD', 'role': 'CONTACT', 'email': 'ipoves@parcdesalutmar.ca', 'phone': '93 248 32 07'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Monitor', 'investigatorFullName': 'Rita Quesada', 'investigatorAffiliation': 'Hospital del Mar'}}}}