Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-04 @ 12:01 PM
Study NCT ID:
NCT02432794
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leakage', 'timeFrame': '7 days', 'description': "investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty.\n\nWhen the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions:\n\nThoracic drain output of oesophagogastric content with amylase \\> 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)"}], 'secondaryOutcomes': [{'measure': 'plasty ischemia', 'timeFrame': '7 days', 'description': 'investigators will consider plasty ischemia when one or more of the following criteria is present:\n\n* endoscopic evidence of gastric mucosa ischemia\n* evidence of low captation of the plasty in a thoracoabdominal CT with endovenous contrast that requires a reintervention.\n* intraoperative mortality (during hospitalization and/or 30 days after surgery).'}, {'measure': 'hospital stay', 'timeFrame': '90 days', 'description': 'investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital'}, {'measure': 'major and minor morbidity', 'timeFrame': '90 days', 'description': 'investigators will evaluate morbidity according to Clavien-Dindo classification'}, {'measure': 'postoperative mortality', 'timeFrame': 'during hospitalization and/or 30 days after surgery'}, {'measure': 'post-embolization morbidity', 'timeFrame': '30 days', 'description': 'investigators will consider post-embolization morbidity the following situations:\n\n* abdominal pain with EVA\\>3 (evaluated by EVA classification )\n* pancreatitis diagnosed by abdominal pain and amylase \\> 5 uKat/L or by CT.\n* abscess, pseudocyst diagnosed by CT or during oesophageal surgery\n* spleen ischemia diagnosed by CT or abdominal ultrasound and needs some treatment\n* liver ischemia diagnosed by Ct or abdominal ultrasound\n* bleeding or artery dissection diagnosed during the embolization and needs some treatment\n* arterial pseudoaneurism diagnosed during the embolization or by CT'}, {'measure': 'anastomotic stricture', 'timeFrame': '6 months', 'description': 'investigators will consider anastomotic stricture when they observe a reduction of anastomotic diameter by oral contrast Rx and needs some treatment (endoscopic dilation or reintervention)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Anastomotic Leak']}, 'referencesModule': {'references': [{'pmid': '17192218', 'type': 'RESULT', 'citation': 'Gonzalez-Gonzalez JJ, Sanz-Alvarez L, Marques-Alvarez L, Navarrete-Guijosa F, Martinez-Rodriguez E. [Complications of surgical resection of esophageal cancer]. Cir Esp. 2006 Dec;80(6):349-60. doi: 10.1016/s0009-739x(06)70987-3. Spanish.'}, {'pmid': '12403940', 'type': 'RESULT', 'citation': 'Schroder W, Beckurts KT, Stahler D, Stutzer H, Fischer JH, Holscher AH. Microcirculatory changes associated with gastric tube formation in the pig. Eur Surg Res. 2002 Nov-Dec;34(6):411-7. doi: 10.1159/000065709.'}, {'pmid': '23583091', 'type': 'RESULT', 'citation': 'Farran Teixidor L, Llop Talaveron J, Galan Guzman M, Aranda Danso H, Miro Martin M, Bettonica Larranaga C, Estremiana Garcia F, Biondo S. [Surgical outcomes of esophageal cancer resection since the development of an Oesophagogastric Tumour Board]. Cir Esp. 2013 Oct;91(8):517-23. doi: 10.1016/j.ciresp.2012.12.005. Epub 2013 Apr 11. Spanish.'}, {'pmid': '1548890', 'type': 'RESULT', 'citation': 'Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.'}, {'pmid': '11893132', 'type': 'RESULT', 'citation': 'Griffin SM, Shaw IH, Dresner SM. Early complications after Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy: risk factors and management. J Am Coll Surg. 2002 Mar;194(3):285-97. doi: 10.1016/s1072-7515(01)01177-2.'}, {'pmid': '20098986', 'type': 'RESULT', 'citation': 'Schroder W, Holscher AH, Bludau M, Vallbohmer D, Bollschweiler E, Gutschow C. Ivor-Lewis esophagectomy with and without laparoscopic conditioning of the gastric conduit. World J Surg. 2010 Apr;34(4):738-43. doi: 10.1007/s00268-010-0403-x.'}, {'pmid': '15569369', 'type': 'RESULT', 'citation': 'Metzger R, Bollschweiler E, Vallbohmer D, Maish M, DeMeester TR, Holscher AH. High volume centers for esophagectomy: what is the number needed to achieve low postoperative mortality? Dis Esophagus. 2004;17(4):310-4. doi: 10.1111/j.1442-2050.2004.00431.x.'}, {'pmid': '1449294', 'type': 'RESULT', 'citation': 'Liebermann-Meffert DM, Meier R, Siewert JR. Vascular anatomy of the gastric tube used for esophageal reconstruction. Ann Thorac Surg. 1992 Dec;54(6):1110-5. doi: 10.1016/0003-4975(92)90077-h.'}, {'pmid': '9782026', 'type': 'RESULT', 'citation': 'Boyle NH, Pearce A, Hunter D, Owen WJ, Mason RC. Scanning laser Doppler flowmetry and intraluminal recirculating gas tonometry in the assessment of gastric and jejunal perfusion during oesophageal resection. Br J Surg. 1998 Oct;85(10):1407-11. doi: 10.1046/j.1365-2168.1998.00943.x.'}, {'pmid': '7790342', 'type': 'RESULT', 'citation': 'Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.'}, {'pmid': '22292613', 'type': 'RESULT', 'citation': 'Yuan Y, Duranceau A, Ferraro P, Martin J, Liberman M. Vascular conditioning of the stomach before esophageal reconstruction by gastric interposition. Dis Esophagus. 2012 Nov-Dec;25(8):740-9. doi: 10.1111/j.1442-2050.2011.01311.x. Epub 2012 Jan 31.'}, {'pmid': '9881938', 'type': 'RESULT', 'citation': 'Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.'}, {'pmid': '10094991', 'type': 'RESULT', 'citation': 'Isomura T, Itoh S, Endo T, Akiyama S, Maruyama K, Ishiguchi T, Ishigaki T, Takagi H. Efficacy of gastric blood supply redistribution by transarterial embolization: preoperative procedure to prevent postoperative anastomotic leaks following esophagoplasty for esophageal carcinoma. Cardiovasc Intervent Radiol. 1999 Mar-Apr;22(2):119-23. doi: 10.1007/s002709900346.'}, {'pmid': '18477261', 'type': 'RESULT', 'citation': 'Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x.'}, {'pmid': '21040153', 'type': 'RESULT', 'citation': 'Farran L, Miro M, Alba E, Bettonica C, Aranda H, Galan M, Rafecas A. Preoperative gastric conditioning in cervical gastroplasty. Dis Esophagus. 2011 May;24(4):205-10. doi: 10.1111/j.1442-2050.2010.01115.x. Epub 2010 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.', 'detailedDescription': "Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports).\n\nThe most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question.\n\nFor this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage.\n\nWe decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer\n* 18 or above years old\n* Acceptance and signing the full informed consent\n\nExclusion Criteria:\n\n* Absence of pancreatitis\n* Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)\n* refuse to collaborate in the study'}, 'identificationModule': {'nctId': 'NCT02432794', 'acronym': 'APIL_2013', 'briefTitle': 'Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.', 'orgStudyIdInfo': {'id': 'APIL_2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'delay phenomenon by arteriography', 'description': 'intervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.\n\nAn angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well.', 'interventionNames': ['Procedure: delay phenomenon by arteriographic approach']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': "Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection"}], 'interventions': [{'name': 'delay phenomenon by arteriographic approach', 'type': 'PROCEDURE', 'description': 'we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography', 'armGroupLabels': ['delay phenomenon by arteriography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Leandre Farran Teixidor', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Leandre F Teixidor, Ph D, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bellvitge University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of oesophagogastric surgery department', 'investigatorFullName': 'Leandre Farran Teixidor', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}