Esophagectomy With or Without Prior Ischemic Gastric Preconditioning

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.

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