Clinical trial · Interventional
Esophagectomy With or Without Prior Ischemic Gastric Preconditioning
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
NCT02457299CI-TRIAL-00039871terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Standard of care was modified at the primary institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| One Stage Esophagectomy | Procedure | — | UNRESOLVED |
| Two Stage Esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Two Stage Esophagectomy
- description
- Ischemic gastric preconditioning performed 7-10 prior to esophagectomy
- interventionNames
- Procedure: Two Stage Esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- One Stage Esophagectomy
- description
- Esophagectomy alone
- interventionNames
- Procedure: One Stage Esophagectomy
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDWormuth JK, Heitmiller RF. Esophageal conduit necrosis. Thorac Surg Clin. 2006 Feb;16(1):11-22. doi: 10.1016/j.thorsurg.2006.01.003. PMID 16696279
- BACKGROUNDHonkoop P, Siersema PD, Tilanus HW, Stassen LP, Hop WC, van Blankenstein M. Benign anastomotic strictures after transhiatal esophagectomy and cervical esophagogastrostomy: risk factors and management. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1141-6; discussion 1147-8. doi: 10.1016/s0022-5223(96)70215-5. PMID 8642814
- BACKGROUNDCooke DT, Lin GC, Lau CL, Zhang L, Si MS, Lee J, Chang AC, Pickens A, Orringer MB. Analysis of cervical esophagogastric anastomotic leaks after transhiatal esophagectomy: risk factors, presentation, and detection. Ann Thorac Surg. 2009 Jul;88(1):177-84; discussion 184-5. doi: 10.1016/j.athoracsur.2009.03.035. PMID 19559221
- BACKGROUNDYetasook AK, Leung D, Howington JA, Talamonti MS, Zhao J, Carbray JM, Ujiki MB. Laparoscopic ischemic conditioning of the stomach prior to esophagectomy. Dis Esophagus. 2013 Jul;26(5):479-86. doi: 10.1111/j.1442-2050.2012.01374.x. Epub 2012 Jul 20. PMID 22816598
- BACKGROUNDUrschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3. PMID 7790342
- BACKGROUNDReavis KM, Chang EY, Hunter JG, Jobe BA. Utilization of the delay phenomenon improves blood flow and reduces collagen deposition in esophagogastric anastomoses. Ann Surg. 2005 May;241(5):736-45; discussion 745-7. doi: 10.1097/01.sla.0000160704.50657.32. PMID 15849509
- BACKGROUNDCuenca-Abente F, Assalia A, del Genio G, Rogula T, Nocca D, Ueda K, Gagner M. Laparoscopic partial gastric transection and devascularization in order to enhance its flow. Ann Surg Innov Res. 2008 Jul 7;2:3. doi: 10.1186/1750-1164-2-3.