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Esophagectomy With or Without Prior Ischemic Gastric Preconditioning

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ClinicalTrials.gov Identifier: NCT02457299
Recruitment Status : Terminated (Standard of care was modified at the primary institution)
First Posted : May 29, 2015
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ki Wan Kim, NorthShore University HealthSystem

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Two Stage Esophagectomy Procedure: One Stage Esophagectomy Not Applicable

Detailed Description:

Esophagectomy with gastric pull-up reconstruction is the current preferred operation for either benign or malignant esophageal disease requiring resection. One of the major complications of an esophagectomy with gastric pull-up reconstruction is esophagus-stomach connection (gastric conduit) failure, which carries significant morbidity and mortality. Many factors contribute to the development of gastric conduit failure, but relative decreased blood flow (ischemia) of the tip of the gastric conduit is believed to be one major factor. This is due to the sacrifice of 3 of the 5 gastric blood supplies leaving the tip of the conduit to rely on collateral vessels. In an effort to improve perfusion to the gastric conduit and to minimize ischemia, the relatively novel approach of ischemic gastric preconditioning was devised, but without concrete evidence to show an advantage of a reduction in gastric conduit failures.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Trial of Esophagectomy and Cervical Esophagogastrostomy With (Two-stage) or Without (One-stage) Prior Ischemic Gastric Preconditioning by Laparoscopic Ligation of Left Gastric and Short Gastric Arteries
Study Start Date : May 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Two Stage Esophagectomy
Ischemic gastric preconditioning performed 7-10 prior to esophagectomy
Procedure: 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

Active Comparator: One Stage Esophagectomy
Esophagectomy alone
Procedure: One Stage Esophagectomy
Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.




Primary Outcome Measures :
  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. [ Time Frame: 7-10 days ]

Secondary Outcome Measures :
  1. Mortality rates in both groups [ Time Frame: 30-90 days ]
  2. Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy [ Time Frame: Hospital inpatient stay, an expected average of a week ]
  3. Nutritional status of one-stage versus two-stage esophagectomy [ Time Frame: Within 30-days of surgery as compared with 3 and 12 month follow-up time points ]
    This will be determined by prealbumin and albumin values

  4. Quality of Life (QOL) scores of patients in both arms [ Time Frame: baseline and up to 24 months postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457299


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Ki Wan Kim
Investigators
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Principal Investigator: Ki Wan Kim, MD NorthShore University HealthSystem

Publications:

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Responsible Party: Ki Wan Kim, Clinician Educator, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02457299     History of Changes
Other Study ID Numbers: EH15-175
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ki Wan Kim, NorthShore University HealthSystem:
Esophagectomy
Gastric Conduit
Esophageal Cancer

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases