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

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 - GREEN-EX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002536-32-IT

Enrollment

Registered

2023-02-06

Start date

2023-07-06

Completion date

Unknown

Last updated

2024-12-16

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 MedDRA version: 21.1 Level: LLT Classification code 10014758 Term: Endometrial neoplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10008354 Term: Cervix neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10047777

Interventions

Product Name: Verdye Product Code: [NA] Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: verde indocianina Current Sponsor code: NA Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >=18 years; - Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed, - Estimated life expectancy of at least 4 weeks; - Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Allergy to iodine; - Patients undergoing only posterior pelvic exenteration; - Patients undergoing ureterostomy; - Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive); - Refusal to sign written informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of the study is to assess the incidence of benign ureteric strictures in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit;Secondary Objective: - To assess the feasibility and safety of this technique. - To evaluate the incidence of ureteric leak in these patients - To assess the oncological outcomes in this population.;Primary end point(s): The primary endpoint of the study is to evaluate the rate of benign uretero-enteric stricture;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: The primary endpoint of the study is to assess the incidence of benign ureteric strictures in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit;Secondary Objective: - To assess the feasibility and safety of this technique. - To evaluate the incidence of ureteric leak in these patients - To assess the oncological outcomes in this population.;Primary end point(s): The primary endpoint of the study is to evaluate the rate of benign uretero-enteric stricture;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate the rate of Clavien Dindo grade three and four post-operative complications.; To assess rate of ureteric leak in this population; To assess 12-months overall survival (OS) and progression free survival (PFS);Timepoint(s) of evaluation of this end point: 24 month; 24 month; 12 months	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica

Fondazione Policlinico Universitario A. Gemelli IRCCS

direzione.scientifica@policlinicogemelli.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026