Clinical trial NCT02457299: Esophagectomy With or Without Prior Ischemic Gastric Preconditioning
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophagectomy
Gastric Conduit
Esophageal Cancer
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 7-10 days
Secondary outcomes:
measure: Mortality rates in both groups
timeFrame: 30-90 days
measure: Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy
timeFrame: Hospital inpatient stay, an expected average of a week
measure: Nutritional status of one-stage versus two-stage esophagectomy
timeFrame: Within 30-days of surgery as compared with 3 and 12 month follow-up time points
measure: Quality of Life (QOL) scores of patients in both arms
timeFrame: baseline and up to 24 months postoperatively
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Ki Wan Kim, MD
role: PRINCIPAL_INVESTIGATOR
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