Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05668260
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2022-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)', 'timeFrame': 'from three days after surgery until 3 months after surgery', 'description': 'The primary objective of the study is to compare the rate of CR-POPF after PD with duct-to-mucosa pancreatico-jejunostomy (PJ) using biodegradable pancreatic internal stent vs no stent.'}], 'secondaryOutcomes': [{'measure': 'Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity', 'timeFrame': 'from three days after surgery until 3 months after surgery', 'description': 'The difference between the two treatment arms in terms of severity of CR-POPF will be assessed. CR-POPF will be classified according to the ISGPS definition into two groups: grade B and grade C. Grade B will be further sub-classified in three categories according to Maggino et al.: grade B1, grade B2, grade B3.'}, {'measure': 'Postoperative Morbidity', 'timeFrame': 'from the date of surgery, up to 3 months', 'description': 'The difference between the two treatment arms in terms of rate of overall postoperative morbidity as defined by Dindo et al. will be assessed. Additionally the Comprehensive Complication Index will be calculated. Post-pancreatectomy hemorrhage (PPH) and delayed gastric emptying (DGE) will be defined according to ISGPS definitions.'}, {'measure': 'Length of Hospital Stay (LOS)', 'timeFrame': 'from the date of surgery until the date of hospital discharge, assessed up to 3 months', 'description': 'The difference between the two treatment arms in terms of median LOS will be assessed. Median LOS will be defined by subtracting the date of surgery from the date when the enrolled patients are discharged from the hospital.'}, {'measure': 'Time to Functional Recovery (TFR)', 'timeFrame': 'from the date of surgery until the date of functional recovery, assessed up to 3 months', 'description': 'The difference between the two treatment arms in terms of time to functional recovery (TFR) will be assessed. TFR will be defined by subtracting the date of surgery from the date when participants achieve standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilise and self-care and no evidence of untreated medical problems).'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'from the day before surgery until 3 months after surgery', 'description': 'The difference between the two treatment arms in terms of QoL will be assessed. QoL will be measured in several ways. First, self-reported activity status will be measured using the Duke Activity Status Index (Duke Index, DASI)., a brief questionnaire designed to assess physical function and predict exercise capacity (peak oxygen uptake). Second, generic health related QoL will be measured using the Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile v2.1 (PROPr), a questionnaire designed to measure self-reported physical, mental and social health and wellbeing.'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'from the date of surgery, up to 3 months', 'description': 'The difference between the two treatment arms in terms of cost-effectiveness will be assessed. Cost-effectiveness will be estimated by the ration of differences in costs to differences in quality adjusted life years (QALYs) between the two groups of the study. QALYs will be calculated using the preference scores obtained from PROMIS-29+2. To calculate QALYs, the preference scores at 90 days after surgery will be multiplied by 0.25 (which represents 1/4 of the year). Cost of care will be estimated considering resources consumed during hospital stay and use of healthcare resources after hospital discharge.'}, {'measure': 'Stent displacement', 'timeFrame': '10 days after surgery', 'description': 'The rate of biodegradable rate displacement as detected by postoperative contrast-enhanced computed tomography (CE-CT) performed by 10 days after surgery. A displacement will be defined by the absence of visible trans-anastomotic stent or by its complete dislocation in the jejunum/ileum or colon.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic surgery', 'Pancreatoduodenectomy', 'CR-POPF', 'Post operative complications', 'ARCHIMEDES™'], 'conditions': ['Pancreatoduodenectomy', 'Clinically Relevant Postoperative Pancreatic Fistula', 'Internal Biodegradable Pancreatic Stent']}, 'referencesModule': {'references': [{'pmid': '23295957', 'type': 'BACKGROUND', 'citation': 'Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.'}, {'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.'}, {'pmid': '30419630', 'type': 'BACKGROUND', 'citation': 'Marchegiani G, Andrianello S, Salvia R, Bassi C. Current Definition of and Controversial Issues Regarding Postoperative Pancreatic Fistulas. Gut Liver. 2019 Mar 15;13(2):149-153. doi: 10.5009/gnl18229.'}, {'pmid': '33933282', 'type': 'BACKGROUND', 'citation': 'Partelli S, Andreasi V, Schiavo Lena M, Rancoita PMV, Mazza M, Mele S, Guarneri G, Pecorelli N, Crippa S, Tamburrino D, Doglioni C, Falconi M. The role of acinar content at pancreatic resection margin in the development of postoperative pancreatic fistula and acute pancreatitis after pancreaticoduodenectomy. Surgery. 2021 Oct;170(4):1215-1222. doi: 10.1016/j.surg.2021.03.047. Epub 2021 Apr 28.'}, {'pmid': '31445782', 'type': 'BACKGROUND', 'citation': 'Smits FJ, Molenaar IQ, Besselink MG, Borel Rinkes IHM, van Eijck CHJ, Busch OR, van Santvoort HC; Dutch Pancreatic Cancer Group. Early recognition of clinically relevant postoperative pancreatic fistula: a systematic review. HPB (Oxford). 2020 Jan;22(1):1-11. doi: 10.1016/j.hpb.2019.07.005. Epub 2019 Aug 21.'}, {'pmid': '28027816', 'type': 'BACKGROUND', 'citation': 'Shrikhande SV, Sivasanker M, Vollmer CM, Friess H, Besselink MG, Fingerhut A, Yeo CJ, Fernandez-delCastillo C, Dervenis C, Halloran C, Gouma DJ, Radenkovic D, Asbun HJ, Neoptolemos JP, Izbicki JR, Lillemoe KD, Conlon KC, Fernandez-Cruz L, Montorsi M, Bockhorn M, Adham M, Charnley R, Carter R, Hackert T, Hartwig W, Miao Y, Sarr M, Bassi C, Buchler MW; International Study Group of Pancreatic Surgery (ISGPS). Pancreatic anastomosis after pancreatoduodenectomy: A position statement by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2017 May;161(5):1221-1234. doi: 10.1016/j.surg.2016.11.021. Epub 2016 Dec 24.'}, {'pmid': '29588609', 'type': 'BACKGROUND', 'citation': 'Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.'}, {'pmid': '22622664', 'type': 'BACKGROUND', 'citation': 'Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24.'}, {'pmid': '27153248', 'type': 'BACKGROUND', 'citation': 'Dong Z, Xu J, Wang Z, Petrov MS. Stents for the prevention of pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2016 May 6;2016(5):CD008914. doi: 10.1002/14651858.CD008914.pub3.'}, {'pmid': '21368658', 'type': 'BACKGROUND', 'citation': 'Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Federation de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.'}, {'pmid': '32101272', 'type': 'BACKGROUND', 'citation': 'Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035.'}, {'pmid': '23122535', 'type': 'BACKGROUND', 'citation': 'Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.'}, {'pmid': '24870390', 'type': 'BACKGROUND', 'citation': 'Braga M, Pecorelli N, Ariotti R, Capretti G, Greco M, Balzano G, Castoldi R, Beretta L. Enhanced recovery after surgery pathway in patients undergoing pancreaticoduodenectomy. World J Surg. 2014 Nov;38(11):2960-6. doi: 10.1007/s00268-014-2653-5.'}, {'pmid': '31082914', 'type': 'BACKGROUND', 'citation': 'Maggino L, Malleo G, Bassi C, Allegrini V, McMillan MT, Borin A, Chen B, Drebin JA, Ecker BL, Fraker DL, Lee MK, Paiella S, Roses RE, Salvia R, Vollmer CM Jr. Decoding Grade B Pancreatic Fistula: A Clinical and Economical Analysis and Subclassification Proposal. Ann Surg. 2019 Jun;269(6):1146-1153. doi: 10.1097/SLA.0000000000002673.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '23728278', 'type': 'BACKGROUND', 'citation': 'Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.'}, {'pmid': '17629996', 'type': 'BACKGROUND', 'citation': 'Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.'}, {'pmid': '17981197', 'type': 'BACKGROUND', 'citation': 'Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.'}, {'pmid': '9076377', 'type': 'BACKGROUND', 'citation': 'Alonso J, Permanyer-Miralda G, Cascant P, Brotons C, Prieto L, Soler-Soler J. Measuring functional status of chronic coronary patients. Reliability, validity and responsiveness to clinical change of the reduced version of the Duke Activity Status Index (DASI). Eur Heart J. 1997 Mar;18(3):414-9. doi: 10.1093/oxfordjournals.eurheartj.a015260.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF).\n\nPatients undergoing PD will be randomized into two arms:\n\n* arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis\n* arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis\n\nThe rate of occurrence of CR-POPF will be compared between the two arms.', 'detailedDescription': 'Clinically relevant postoperative pancreatic fistula (CR-POPF) represents the most common complication that can occur after pancreatoduodenectomy (PD). CR-POPF is the main cause of morbidity after PD, being associated with a risk of mortality up to 60%. The placement of external or internal pancreatic stents after PD have been investigated as possible strategies for preventing the development of CR-POPF. However, device displacement has been reported as a common cause of pancreatic stents malfunction. Recently, a novel biodegradable pancreatic stent (ARCHIMEDES™) has been introduced. The device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of CR-POPF after PD.\n\nIn this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing PD versus no stenting, focusing on a possible superiority association for preventing CR-POPF.\n\nParticipants will be randomised into two arms (Biodegradable stent vs non-stent) based on their intra-operative risk of developing POPF according to the Fistula Risk Score (FRS). The rate of CR-POPF will be compared between the two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Patients who undergo pancreatoduodenectomy (PD)\n* Informed Consent\n\nExclusion Criteria:\n\n* Previous distal pancreatectomy\n* Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \\< 7)'}, 'identificationModule': {'nctId': 'NCT05668260', 'acronym': 'BioSteP', 'briefTitle': 'Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BioSteP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biodegradable Stent', 'description': 'An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.', 'interventionNames': ['Device: Biodegradable Stent']}, {'type': 'NO_INTERVENTION', 'label': 'Non Stent', 'description': 'No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.'}], 'interventions': [{'name': 'Biodegradable Stent', 'type': 'DEVICE', 'description': 'A trans-anastomotic biodegradable internal stent (ARCHIMEDES™) will be placed between the main pancreatic duct (MPD) and the enterotomy in the jejunum just after the completion of the posterior suture of duct-to-mucosa. The biodegradable stent will then be shaped according to the angle of the jejunal loop in order to minimise the risk of displacement. The adequate length of the stent will be chosen according to the length of the jejunal loop.', 'armGroupLabels': ['Biodegradable Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Falconi, Professor', 'role': 'CONTACT', 'email': 'falconi.massimo@hsr.it', 'phone': '0039 022643 6046'}, {'name': 'Stefano Partelli, Professor', 'role': 'CONTACT', 'email': 'partelli.stefano@hsr.it', 'phone': '0039 022643 7697'}, {'name': 'Stefano Partelli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Massimo Falconi, Professor', 'role': 'CONTACT', 'email': 'falconi.massimo@hsr.it', 'phone': '0039 022643 6046'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'amg International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stefano Partelli', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}