Morbidity in Open Versus Minimally Invasive Esophagectomy
MIOMIE
Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedJanuary 27, 2017
January 1, 2017
4.6 years
January 25, 2017
January 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
morbidity
anastomotic leakage, gastric conduit necrosis and/or pneumonia
30 days
mortality
30 days
Secondary Outcomes (4)
ICU stay
90 days
hospital stay
90 days
overall survival
5 years
relapse free survival
5 years
Study Arms (2)
minimally invasive esophagectomy
EXPERIMENTALminimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.
open esophagectomy
ACTIVE COMPARATORopen gastric mobilization and gastric tube formation
Interventions
In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.
in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Medical 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: 12049861BACKGROUNDCunningham 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: 16822992BACKGROUNDLow 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: 17763917BACKGROUNDSchoppmann 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: 20464423BACKGROUNDSchwameis 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: 23645759BACKGROUNDMessager 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.
PMID: 26583671BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 27, 2017
Study Start
May 1, 2010
Primary Completion
November 19, 2014
Study Completion
April 18, 2016
Last Updated
January 27, 2017
Record last verified: 2017-01