Esophagectomy With or Without Prior Ischemic Gastric Preconditioning

Not Applicable

Terminated

• Conditions: Esophageal Cancer
• Interventions: Procedure: One Stage Esophagectomy; Procedure: Two Stage Esophagectomy

• Registration Number: NCT02457299
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-04-21
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One Stage Esophagectomy	One Stage Esophagectomy	Esophagectomy alone
Two Stage Esophagectomy	Two Stage Esophagectomy	Ischemic gastric preconditioning performed 7-10 prior to esophagectomy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	This will be determined by prealbumin and albumin values
Quality of Life (QOL) scores of patients in both arms	baseline and up to 24 months postoperatively
Mortality rates in both groups	30-90 days

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States