Esophagectomy With or Without Prior Ischemic Gastric Preconditioning
NCT ID: NCT02457299
Last Updated: 2019-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2015-05-31
2016-11-30
Brief Summary
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Detailed Description
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Patients meeting eligibility criteria and agree to participation in the study will be randomized to either a esophagectomy with (two-stage) or without (one-stage) ischemic gastric preconditioning and the incidence of gastric conduit failure will be compared. Those randomized to a two-stage procedure will have laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection done 7-10 days prior to an esophagectomy and those randomized to a one-stage procedure will only have the esophagectomy performed.
Validated quality of life (QOL) questionnaires will be completed at the preoperative visit as well as on the day of discharge and at postoperative follow-up timepoints: 3 weeks, 3 months, 6 months, 12 months and 24 months. Data collection will be mostly collected through electronic medical record review and will include, but is not limited to: demographic data; imaging and laboratory values; past medical, surgical and social history; inpatient and intraoperative data; and vitals signs. Patients will be assessed for adverse events throughout study participation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Two Stage Esophagectomy
Ischemic gastric preconditioning performed 7-10 prior to esophagectomy
Two Stage Esophagectomy
Patients will undergo laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection 7-10 days prior to an esophagectomy with gastric pull-up reconstruction
One Stage Esophagectomy
Esophagectomy alone
One Stage Esophagectomy
Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.
Interventions
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Two Stage Esophagectomy
Patients will undergo laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection 7-10 days prior to an esophagectomy with gastric pull-up reconstruction
One Stage Esophagectomy
Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.
Eligibility Criteria
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Inclusion Criteria
* Subject is a candidate for esophagectomy with or without gastric pre-conditioning procedure per thoracic surgeon
* Patient is at least 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Cancer stage: T1-2-3 N0M0, Locally advanced, T2-3 N1M0 based on American Joint Committee on Cancer (AJCC) 7th Edition by the oncologist
* No definitive radiological evidence of distant metastases as evaluated by CT or PET/CT scan
* Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including follow-up visits.
Exclusion Criteria
* History of invasive cancer within the past 5 years, (exceptions: non melanoma skin cancer, in situ cancers)
* Prior upper abdominal surgeries performed open and/or laparoscopic; such as but not limited to Nissen fundoplication, gastrectomy, bariatric surgery, hiatus hernia repair.
* Subject is participating in another investigational trial
* Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding
* Subject is part of the site personnel directly involved with this study
* Subject is a family member of the investigational study staff
18 Years
ALL
No
Sponsors
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Endeavor Health
OTHER
Responsible Party
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Principal Investigators
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Ki Wan Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Locations
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NorthShore University HealthSystem
Evanston, Illinois, United States
Countries
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References
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Wormuth JK, Heitmiller RF. Esophageal conduit necrosis. Thorac Surg Clin. 2006 Feb;16(1):11-22. doi: 10.1016/j.thorsurg.2006.01.003.
Honkoop P, Siersema PD, Tilanus HW, Stassen LP, Hop WC, van Blankenstein M. Benign anastomotic strictures after transhiatal esophagectomy and cervical esophagogastrostomy: risk factors and management. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1141-6; discussion 1147-8. doi: 10.1016/s0022-5223(96)70215-5.
Cooke DT, Lin GC, Lau CL, Zhang L, Si MS, Lee J, Chang AC, Pickens A, Orringer MB. Analysis of cervical esophagogastric anastomotic leaks after transhiatal esophagectomy: risk factors, presentation, and detection. Ann Thorac Surg. 2009 Jul;88(1):177-84; discussion 184-5. doi: 10.1016/j.athoracsur.2009.03.035.
Yetasook AK, Leung D, Howington JA, Talamonti MS, Zhao J, Carbray JM, Ujiki MB. Laparoscopic ischemic conditioning of the stomach prior to esophagectomy. Dis Esophagus. 2013 Jul;26(5):479-86. doi: 10.1111/j.1442-2050.2012.01374.x. Epub 2012 Jul 20.
Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.
Reavis KM, Chang EY, Hunter JG, Jobe BA. Utilization of the delay phenomenon improves blood flow and reduces collagen deposition in esophagogastric anastomoses. Ann Surg. 2005 May;241(5):736-45; discussion 745-7. doi: 10.1097/01.sla.0000160704.50657.32.
Cuenca-Abente F, Assalia A, del Genio G, Rogula T, Nocca D, Ueda K, Gagner M. Laparoscopic partial gastric transection and devascularization in order to enhance its flow. Ann Surg Innov Res. 2008 Jul 7;2:3. doi: 10.1186/1750-1164-2-3.
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.
Bludau M, Holscher AH, Vallbohmer D, Gutschow C, Schroder W. Ischemic conditioning of the gastric conduit prior to esophagectomy improves mucosal oxygen saturation. Ann Thorac Surg. 2010 Oct;90(4):1121-6. doi: 10.1016/j.athoracsur.2010.06.003.
Oezcelik A, Banki F, DeMeester SR, Leers JM, Ayazi S, Abate E, Hagen JA, Lipham JC, DeMeester TR. Delayed esophagogastrostomy: a safe strategy for management of patients with ischemic gastric conduit at time of esophagectomy. J Am Coll Surg. 2009 Jun;208(6):1030-4. doi: 10.1016/j.jamcollsurg.2009.02.055. Epub 2009 Apr 24.
Holscher AH, Schneider PM, Gutschow C, Schroder W. Laparoscopic ischemic conditioning of the stomach for esophageal replacement. Ann Surg. 2007 Feb;245(2):241-6. doi: 10.1097/01.sla.0000245847.40779.10.
Nguyen NT, Longoria M, Sabio A, Chalifoux S, Lee J, Chang K, Wilson SE. Preoperative laparoscopic ligation of the left gastric vessels in preparation for esophagectomy. Ann Thorac Surg. 2006 Jun;81(6):2318-20. doi: 10.1016/j.athoracsur.2005.05.033.
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.
Sepesi B, Swisher SG, Walsh GL, Correa A, Mehran RJ, Rice D, Roth J, Vaporciyan A, Hofstetter WL. Omental reinforcement of the thoracic esophagogastric anastomosis: an analysis of leak and reintervention rates in patients undergoing planned and salvage esophagectomy. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1146-50. doi: 10.1016/j.jtcvs.2012.07.085. Epub 2012 Aug 28.
Varela E, Reavis KM, Hinojosa MW, Nguyen N. Laparoscopic gastric ischemic conditioning prior to esophagogastrectomy: technique and review. Surg Innov. 2008 Jun;15(2):132-5. doi: 10.1177/1553350608317352. Epub 2008 May 13.
Other Identifiers
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EH15-175
Identifier Type: -
Identifier Source: org_study_id
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