Esophagectomy With or Without Prior Ischemic Gastric Preconditioning

NCT02457299 | Terminated

• 1 other identifier: EH15-175
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center, randomized prospective clinical trial involves esophageal cancer patients who are surgical candidates. Patients will be randomized either to the one stage or the two stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis from both types of procedure will be reviewed and compared.

Conditions

Esophageal Cancer

Keywords

Esophagectomy; Gastric Conduit; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• The number of participants with gastric conduit failures as a measure of safety and tolerability in the one-stage esophagectomy as compared with the two-stage esophagectomy.

  7-10 days

Secondary Outcomes (4)

• Mortality rates in both groups

  30-90 days

• Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy

  Hospital inpatient stay, an expected average of a week

• Nutritional status of one-stage versus two-stage esophagectomy

  Within 30-days of surgery as compared with 3 and 12 month follow-up time points

• Quality of Life (QOL) scores of patients in both arms

  baseline and up to 24 months postoperatively

Study Arms (2)

Two Stage Esophagectomy

ACTIVE COMPARATOR

Ischemic gastric preconditioning performed 7-10 prior to esophagectomy

Procedure: Two Stage Esophagectomy

One Stage Esophagectomy

ACTIVE COMPARATOR

Esophagectomy alone

Procedure: One Stage Esophagectomy

Interventions

Two Stage Esophagectomy PROCEDURE

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

Two Stage Esophagectomy

One Stage Esophagectomy PROCEDURE

Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.

One Stage Esophagectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is willing and able to provide written informed consent
• 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.

You may not qualify if:

• Patients \< 18 years old
• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (15)

• Wormuth JK, Heitmiller RF. Esophageal conduit necrosis. Thorac Surg Clin. 2006 Feb;16(1):11-22. doi: 10.1016/j.thorsurg.2006.01.003.

  PMID: 16696279 BACKGROUND

• 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.

  PMID: 8642814 BACKGROUND

• 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.

  PMID: 19559221 BACKGROUND

• 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.

  PMID: 22816598 BACKGROUND

• 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: 7790342 BACKGROUND

• 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.

  PMID: 15849509 BACKGROUND

• 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.

  PMID: 18606017 BACKGROUND

• 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: 9881938 BACKGROUND

• 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.

  PMID: 20868800 BACKGROUND

• 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.

  PMID: 19476888 BACKGROUND

• 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.

  PMID: 17245177 BACKGROUND

• 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.

  PMID: 16731189 BACKGROUND

• 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: 20098986 BACKGROUND

• 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.

  PMID: 22939861 BACKGROUND

• 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.

  PMID: 18480085 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Ki Wan Kim, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 29, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)