Feasibility of Pre-emptive VACStent Placement after Ivor Lewis Esophagectomy, to Prevent Anastomotic Leakage (PREVENT feasibility study)

Feasibility of Pre-emptive VACStent Placement after Ivor Lewis Esophagectomy, to Prevent Anastomotic Leakage (PREVENT feasibility study) - PREVENT feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57220

Enrollment

Registered

2024-03-18

Start date

2024-12-10

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Esophageal anastomotic leakage leakage in the esophagus

Interventions

Endoscopic placement of a pre-emptive VACStent, right after Ivor Lewis esophagectomy in the operation room, and removal after 5-7 days.

Eligibility

Inclusion criteria

Inclusion criteria: Undergoing an esophagectomy with gastric conduit reconstruction and intrathoracic anastomosis (Ivor Lewis) at the Amsterdam UMC

Exclusion criteria

Exclusion criteria: Patients with contra-indications for endoscopic vacuum therapy: defect length larger than 5 cm, defect less than 2cm from the proximal esophageal sphincter and ileus. Patients unable to sign informed consent.

Design outcomes

Primary

Measure	Time frame
Evaluate the technical and logistic feasibility and safety of pre-emptive VACStent placement in patients undergoing esophagectomy with gastric conduit reconstruction and intrathoracic anastomosis to prevent anastomotic leakage	—

Secondary

Measure	Time frame
- To study the rate of anastomotic leakage - To study the quality of life/quality of recovery - To study the length of ICU- and in-hospital stay - To study the 30-day morbidity and mortality	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026