ISCON trial - Laparoscopic ISchemic CONditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications

ISCON trial - Laparoscopic ISchemic CONditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications - ISCON trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50061

Enrollment

Registered

2019-03-27

Start date

2020-10-16

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Esophageal cancer

Interventions

Laparoscopic ISCON followed by esophagectomy after an interval of 12-18 days.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with *major calcifications* of the thoracic aorta (UCS) or stenosis of the celiac axis (modified NASCET score) on preoperative CT scan, who are planned to undergo transthoracic of transhiatal esophagectomy.

Exclusion criteria

Exclusion criteria: Not able to undergo study treatment (surgery). Metastatic disease (M1)

Design outcomes

Primary

Measure	Time frame
all complications grade 2 and higher (Clavien-Dindo classification) occurring during or after operation 1 (laparoscopic ISCON) and before operation 2 (esophagectomy).	—

Secondary

Measure	Time frame
secondary outcomes with regard to operation 1 (laparoscopic ISCON) are the duration of the procedure, blood loss, day of discharge postoperatively and grade 1 complications. Secondary outcomes with regard to operation 2 (esophagectomy) are anastomotic leakage rate, all other grade *3b complications and 30 day mortality. Further secondary endpoints are the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography.	—

Measure

Time frame

secondary outcomes with regard to operation 1 (laparoscopic ISCON) are the duration of the procedure, blood loss, day of discharge postoperatively and grade 1 complications. Secondary outcomes with regard to operation 2 (esophagectomy) are anastomotic leakage rate, all other grade *3b complications and 30 day mortality. Further secondary endpoints are the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)