Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial.
Cancer of the oesophagogastric junction
Oesophageal neoplasms
Oesophagectomy
Patient-reported outcome measures
Postoperative complications
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
10 Mar 2023
10 Mar 2023
Historique:
received:
30
11
2022
accepted:
04
02
2023
entrez:
10
3
2023
pubmed:
11
3
2023
medline:
15
3
2023
Statut:
epublish
Résumé
Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity. The MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes. The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity. DRKS00027927 U1111-1277-0214. Registered on 4th July 2022.
Sections du résumé
BACKGROUND
BACKGROUND
Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity.
METHODS
METHODS
The MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes.
DISCUSSION
CONCLUSIONS
The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity.
TRIAL REGISTRATION
BACKGROUND
DRKS00027927 U1111-1277-0214. Registered on 4th July 2022.
Identifiants
pubmed: 36899404
doi: 10.1186/s13063-023-07134-1
pii: 10.1186/s13063-023-07134-1
pmc: PMC9999550
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
175Subventions
Organisme : Bundesministerium für Bildung und Forschung
ID : 01KG2028
Informations de copyright
© 2023. The Author(s).
Références
Anesthesiology. 2013 Jun;118(6):1332-40
pubmed: 23411725
Ann Thorac Surg. 2018 Nov;106(5):1484-1491
pubmed: 29944881
J Am Coll Surg. 2014 Jun;218(6):1130-40
pubmed: 24698488
JAMA Oncol. 2017 Apr 01;3(4):524-548
pubmed: 27918777
Eur J Cancer. 2003 Jul;39(10):1384-94
pubmed: 12826041
J Clin Oncol. 2014 Aug 10;32(23):2416-22
pubmed: 24982463
Lancet. 2011 Apr 30;377(9776):1514-22
pubmed: 21529927
Ann Surg. 2018 Jun;267(6):1021-1027
pubmed: 28885510
Ann Thorac Surg. 2020 Mar;109(3):865-871
pubmed: 31706867
Surg Endosc. 2013 Apr;27(4):1346-52
pubmed: 23093242
J Gastrointest Surg. 2012 May;16(5):1055-63
pubmed: 22089950
CA Cancer J Clin. 2017 Jan;67(1):7-30
pubmed: 28055103
Ann Surg. 2017 Aug;266(2):232-236
pubmed: 28187044
Eur Surg. 2018;50(6):249-255
pubmed: 30546384
J Cancer Res Ther. 2018;14(4):789-794
pubmed: 29970654
Ann Surg. 2013 Jul;258(1):1-7
pubmed: 23728278
J Cardiothorac Surg. 2008 Jul 18;3:48
pubmed: 18634549
J Clin Epidemiol. 2015 Dec;68(12):1504-11
pubmed: 25985892
Ann Surg. 2019 Apr;269(4):621-630
pubmed: 30308612
J Gastrointest Surg. 2013 Aug;17(8):1346-51
pubmed: 23690208
J Gastrointest Surg. 2017 Nov;21(11):1757-1763
pubmed: 28900830
N Engl J Med. 2019 Jan 10;380(2):152-162
pubmed: 30625052
Ann Thorac Surg. 2018 Sep;106(3):916-923
pubmed: 29738757
Ann Surg. 2016 Apr;263(4):727-32
pubmed: 26501701
Lancet Oncol. 2007 Jun;8(6):545-53
pubmed: 17540306
J R Coll Surg Edinb. 1992 Feb;37(1):7-11
pubmed: 1573620
Br J Surg. 2022 Feb 24;109(3):283-290
pubmed: 35024794
Ann Surg. 2011 Dec;254(6):907-13
pubmed: 21562405