Minimally invasive esophageal resection for esophageal carcinoma: Restoring continuity of the gastro-intestinal tract at the level of the thorax or at the neck.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28698

Enrollment

200

Registered

2013-12-23

Start date

2016-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Esophageal carcinoma (NL: oesofaguscarcinoom) Minimally invasive esophagectomy (NL: minimaal invasieve slokdarmresectie) Intrathoracic anastomosis (NL: intrathoracale anastomose) Cervical anastomosis (NL: cervicale anastomose)

Interventions

MIE with cervical anastomosis (control group) is compared to MIE with intrathoracic anastomosis (intervention group).

Eligibility

Inclusion criteria

Inclusion criteria: - Age >= 18 years. - Histologically proven esophageal carcinoma from below the carina to the gastro-esophageal junction (Siewert 2). - Resectable tumour (T1b-34a 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. - Secondary, prognosis determining malignancy.

Design outcomes

Primary

Measure	Time frame
Anastomotic leakage for which endoscopic, radiologic or surgical intervention is required.	—

Secondary

Measure	Time frame
Quality of life, benign anastomotic strictures requiring dilatation, reintervention, pulmonary complications, length of stay, mortality, and costs.	—

Contacts

Public ContactF. van Workum

Canisius-Wilhelmina Hospital Surgery Post office box 9015

F.vanworkum@cwz.nl06 21282881

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)