Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518783-13-00

Acronym

GREEN-EX

Enrollment

Registered

2024-11-25

Start date

2023-11-09

Completion date

Unknown

Last updated

2024-11-25

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

Conditions

Patients with gynecological cancers undergoing pelvic exenteration

Brief summary

the overall rate of benign uretero-enteric stricture

Detailed description

Rate of Clavien Dindo grade three and four post-operative complications, both early (within 30 days after surgery) and late (from day 31 to day 180 after surgery), To assess the overall rate of ureteric leak in the study sample, To assess the differences in eGFR (i.e., renal function) over time (baseline, 1, 3 and 6 months) according to fluorescence levels, To assess 12-months overall survival (OS) and progression free survival (PFS)

Interventions

DRUGINDOCYANINE GREEN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the overall rate of benign uretero-enteric stricture	—

Secondary

Measure	Time frame
Rate of Clavien Dindo grade three and four post-operative complications, both early (within 30 days after surgery) and late (from day 31 to day 180 after surgery), To assess the overall rate of ureteric leak in the study sample, To assess the differences in eGFR (i.e., renal function) over time (baseline, 1, 3 and 6 months) according to fluorescence levels, To assess 12-months overall survival (OS) and progression free survival (PFS)	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026