Clinical trial · Interventional
Morbidity in Open Versus Minimally Invasive Esophagectomy
Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
NCT03035071CI-TRIAL-00025663MIOMIEcompletedN/AClinicalTrials.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 MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.
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 |
|---|---|---|---|
| minimally invasive esophagectomy | Procedure | — | UNRESOLVED |
| open esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- minimally invasive esophagectomy
- description
- minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.
- interventionNames
- Procedure: minimally invasive esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- open esophagectomy
- description
- open gastric mobilization and gastric tube formation
- interventionNames
- Procedure: open esophagectomy
Primary outcomes (2)
- measure
- morbidity
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I and II position * esophageal squamous cell cancer * patients, who require esophageal resection due to above mentioned diagnosis * patients, who gave their informed consent Exclusion Criteria: * individuals who did not meet the inclusion criteria were excluded from the study. * patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded. * patients, presenting other than AC or ESCC or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen) * patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma
References
Publications (6)
- BACKGROUNDMedical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8. PMID 12049861
- BACKGROUNDCunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531. PMID 16822992
- BACKGROUNDLow DE, Kunz S, Schembre D, Otero H, Malpass T, Hsi A, Song G, Hinke R, Kozarek RA. Esophagectomy--it's not just about mortality anymore: standardized perioperative clinical pathways improve outcomes in patients with esophageal cancer. J Gastrointest Surg. 2007 Nov;11(11):1395-402; discussion 1402. doi: 10.1007/s11605-007-0265-1. Epub 2007 Aug 31. PMID 17763917
- BACKGROUNDSchoppmann SF, Prager G, Langer FB, Riegler FM, Kabon B, Fleischmann E, Zacherl J. Open versus minimally invasive esophagectomy: a single-center case controlled study. Surg Endosc. 2010 Dec;24(12):3044-53. doi: 10.1007/s00464-010-1083-1. Epub 2010 May 13. PMID 20464423
- BACKGROUNDSchwameis K, Ba-Ssalamah A, Wrba F, Birner P, Prager G, Hejna M, Schmid R, Asari R, Zacherl J, Schoppmann SF. The implementation of minimally-invasive esophagectomy does not impact short-term outcome in a high-volume center. Anticancer Res. 2013 May;33(5):2085-91. PMID 23645759
- BACKGROUNDMessager M, Pasquer A, Duhamel A, Caranhac G, Piessen G, Mariette C; FREGAT working groupFRENCH. Laparoscopic Gastric Mobilization Reduces Postoperative Mortality After Esophageal Cancer Surgery: A French Nationwide Study. Ann Surg. 2015 Nov;262(5):817-22; discussion 822-3. doi: 10.1097/SLA.0000000000001470.