Clinical trial · Observational
European iNvestigation of SUrveillance After Resection for Esophageal Cancer
ENSURE: European iNvestigation of SUrveillance After Resection for Esophageal Cancer
NCT03461341CI-TRIAL-00044264ENSUREcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The ENSURE study will comprise two phases. Phase 1: European multicenter survey of surveillance protocols after esophageal cancer surgery ENSURE questionnaire will be circulated to representatives from participating European countries. Phase 2: European multicenter retrospective observational study of the impact of postoperative surveillance protocols on oncologic outcome and HR-QL Phase 2 will constitute a retrospective observational study of patients undergoing treatment with curative intent for esophageal cancer at participating Centers from June 2009 to June 2015.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Radiation | — | UNRESOLVED | — |
| Recurrent Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High intensity postoperative oncologic surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients post curative intent surgery for esophageal cancer
- description
- Patients post potentially curative surgery for cTxNxM0 esophageal or esophagogastric junction (Siewert type I, II and III) cancer.
- interventionNames
- Other: High intensity postoperative oncologic surveillance
Primary outcomes (3)
- measure
- Overall survival (months)
- timeFrame
- Minimum 3 year follow-up for all patients
- description
- Overall survival in months will be compared by Kaplan-Meier methods and using multivariable Cox proportional hazards regression, adjusting for known prognostic factors, to determine the independent impact of high intensity surveillance on survival outcome.
- measure
- Disease-specific survival (months)
- timeFrame
- Minimum 3 year follow-up for all patients
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Age 18 years and above 2. Underwent surgery with curative intent for cTxNxM0 esophageal or esophagogastric junction (Siewert type I, II and III) cancer 3. Salvage surgery after failure of primary endoscopic or oncologic treatment will be included Exclusion criteria 1. Endoscopic therapy or definitive oncological treatment as sole therapy for esophageal cancer 2. Missing follow-up data
References
Publications (7)
- BACKGROUNDAntonowicz SS, Lorenzi B, Parker M, Tang CB, Harvey M, Kadirkamanathan SS. Annual computed tomography scans do not improve outcomes following esophagectomy for cancer: a 10-year UK experience. Dis Esophagus. 2015 May-Jun;28(4):365-70. doi: 10.1111/dote.12209. Epub 2014 Mar 20. PMID 24649807
- BACKGROUNDMessager M, de Steur W, Boelens PG, Jensen LS, Mariette C, Reynolds JV, Osorio J, Pera M, Johansson J, Kolodziejczyk P, Roviello F, De Manzoni G, Monig SP, Allum WH; EURECCA Upper GI group (European Registration of Cancer Care). Description and analysis of clinical pathways for oesophago-gastric adenocarcinoma, in 10 European countries (the EURECCA upper gastro intestinal group - European Registration of Cancer Care). Eur J Surg Oncol. 2016 Sep;42(9):1432-47. doi: 10.1016/j.ejso.2016.01.001. Epub 2016 Feb 6. PMID 26898839
- BACKGROUNDPeixoto RD, Lim HJ, Kim H, Abdullah A, Cheung WY. Patterns of surveillance following curative intent therapy for gastroesophageal cancer. J Gastrointest Cancer. 2014 Sep;45(3):325-33. doi: 10.1007/s12029-014-9601-3. PMID 24756830
- BACKGROUNDDepypere L, Lerut T, Moons J, Coosemans W, Decker G, Van Veer H, De Leyn P, Nafteux P. Isolated local recurrence or solitary solid organ metastasis after esophagectomy for cancer is not the end of the road. Dis Esophagus. 2017 Jan 1;30(1):1-8. doi: 10.1111/dote.12508. PMID 27704661
- BACKGROUNDSisic L, Strowitzki MJ, Blank S, Nienhueser H, Dorr S, Haag GM, Jager D, Ott K, Buchler MW, Ulrich A, Schmidt T. Postoperative follow-up programs improve survival in curatively resected gastric and junctional cancer patients: a propensity score matched analysis. Gastric Cancer. 2018 May;21(3):552-568. doi: 10.1007/s10120-017-0751-4. Epub 2017 Jul 24. PMID 28741059
- BACKGROUNDAbate E, DeMeester SR, Zehetner J, Oezcelik A, Ayazi S, Costales J, Banki F, Lipham JC, Hagen JA, DeMeester TR. Recurrence after esophagectomy for adenocarcinoma: defining optimal follow-up intervals and testing. J Am Coll Surg. 2010 Apr;210(4):428-35. doi: 10.1016/j.jamcollsurg.2010.01.006.