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Randomized Controlled Trial
. 2021 Jul 1;156(7):601-610.
doi: 10.1001/jamasurg.2021.1555.

Intrathoracic vs Cervical Anastomosis After Totally or Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial

Frans van Workum  1 , Moniek H P Verstegen  1 , Bastiaan R Klarenbeek  1 , Stefan A W Bouwense  1   2 , Mark I van Berge Henegouwen  3 , Freek Daams  4 , Suzanne S Gisbertz  3 , Gerjon Hannink  5 , Jan Willem Haveman  6 , Joos Heisterkamp  7 , Walther Jansen  7 , Ewout A Kouwenhoven  8 , Jan J B van Lanschot  9 , Grard A P Nieuwenhuijzen  10 , Donald L van der Peet  4 , Fatih Polat  11 , Sander Ubels  1 , Bas P L Wijnhoven  9 , Maroeska M Rovers  5 , Camiel Rosman  1 ; ICAN collaborative research group
Collaborators, Affiliations
Randomized Controlled Trial

Intrathoracic vs Cervical Anastomosis After Totally or Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial

Frans van Workum et al. JAMA Surg. .

Abstract

Background: Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE.

Objective: To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial.

Design, setting, and participants: This open, multicenter randomized clinical superiority trial was performed at 9 Dutch high-volume hospitals. Patients with midesophageal to distal esophageal or gastroesophageal junction cancer planned for curative resection were included. Data collection occurred from April 2016 through February 2020.

Intervention: Patients were randomly assigned (1:1) to transthoracic MIE with intrathoracic or cervical anastomosis.

Main outcomes and measures: The primary end point was anastomotic leakage requiring endoscopic, radiologic, or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality, and quality of life.

Results: Two hundred sixty-two patients were randomized, and 245 were eligible for analysis. Anastomotic leakage necessitating reintervention occurred in 15 of 122 patients with intrathoracic anastomosis (12.3%) and in 39 of 123 patients with cervical anastomosis (31.7%; risk difference, -19.4% [95% CI, -29.5% to -9.3%]). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference, -21.9% [95% CI, -32.1% to -11.6%]). Intensive care unit length of stay, mortality rates, and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with fewer severe complications (risk difference, -11.3% [-20.4% to -2.2%]), lower incidence of recurrent laryngeal nerve palsy (risk difference, -7.3% [95% CI, -12.1% to -2.5%]), and better quality of life in 3 subdomains (mean differences: dysphagia, -12.2 [95% CI, -19.6 to -4.7]; problems of choking when swallowing, -10.3 [95% CI, -16.4 to 4.2]; trouble with talking, -15.3 [95% CI, -22.9 to -7.7]).

Conclusions and relevance: In this randomized clinical trial, intrathoracic anastomosis resulted in better outcome for patients treated with transthoracic MIE for midesophageal to distal esophageal or gastroesophageal junction cancer.

Trial registration: Trialregister.nl Identifier: NL4183 (NTR4333).

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Verstegen reported grants from Netherlands Organization for Health Research (ZonMw) during the conduct of the study. Dr van Berge Henegouwen reported personal fees to his institution from Mylan, Alesi Surgical, Johnson & Johnson, and Medtronic outside the submitted work and grants paid to his institution from Olympus and Stryker outside the submitted work. Dr Ubels reported grants from ZonMw during the conduct of the study and grants from Medtronic outside the submitted work. Dr Rovers reported grants from ZonMw during the conduct of the study and outside the submitted work and grants from Siemens Healthineers outside the submitted work. Dr Rosman reported grants from ZonMw during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. CONSORT Flow Diagram
MIE indicates minimally invasive esophagectomy.
See this image and copyright information in PMC

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