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
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Procedure: Two Stage Esophagectomy Procedure: One Stage Esophagectomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Procedure: One Stage Esophagectomy
Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.
- 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 ]
- Mortality rates in both groups [ Time Frame: 30-90 days ]
- Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy [ Time Frame: Hospital inpatient stay, an expected average of a week ]
- 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
- Quality of Life (QOL) scores of patients in both arms [ Time Frame: baseline and up to 24 months postoperatively ]
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
|United States, Illinois|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Ki Wan Kim, MD||NorthShore University HealthSystem|