Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: a randomized controlled trial

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: a randomized controlled trial - ICAN trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45081

Enrollment

240

Registered

2014-10-02

Start date

2016-06-08

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer esophageal carcinoma

Interventions

(Hybrid) minimally invasive esophagectomy with an intrathoracic esophagogastric anastomosis (intervention group) is compared to (hybrid) minimally invasive esophagectomy with cervical esophagogastri

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years. - Histologically proven esophageal carcinoma below the carina or at the level of the gastro-esophageal junction (Siewert 2). - Resectable tumour (T1b-4a N0-3 M0). - Mental, physical and geographical ability to undergo treatment and follow-up. - Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: - Previous major gastric or major thoracic surgery rendering (hybrid) minimally invasive esophagectomy unfeasible). - Secondary, prognosis determining malignancy.

Design outcomes

Primary

Measure	Time frame
Anastomotic leakage requiring endoscopic, radiologic or surgical reintervention	—

Secondary

Measure	Time frame
Secondary outcome parameters (amongst others): quality of life, functional morbidity, complications, organ failure, reintervention, length of stay, mortality, and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)