Esophagectomy With or Without Prior Ischemic Gastric Preconditioning

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Two Stage Esophagectomy
* Procedure: One Stage Esophagectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two Stage Esophagectomy<br>Ischemic gastric preconditioning performed 7-10 prior to esophagectomy | Procedure: Two Stage Esophagectomy<br>* 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<br>|
| Active Comparator: One Stage Esophagectomy<br>Esophagectomy alone | Procedure: One Stage Esophagectomy<br>* Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This will be determined by prealbumin and albumin values | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagectomy, Gastric Conduit, Esophageal Cancer