Fluorescence-Guided Resection of Colorectal Liver Metastases with Preoperatively Administered Indocyanine Green: A Randomized Controlled Multicenter Trial

Fluorescence-Guided Resection of Colorectal Liver Metastases with Preoperatively Administered Indocyanine Green: A Randomized Controlled Multicenter Trial - GLOWMET: GLOWing METastases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040803

Enrollment

Registered

2026-07-13

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C78.7

Interventions

Group 1: ICG 0.5 mg/kg intravenously 48-96 hours prior to surgery Intraoperative near-infrared imaging will be used to detect ICG-positive lesions and guide resection Group 2: Standard surgery using c

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age =18 years - Histologically or radiologically confirmed colorectal liver metastases (CRLM) scheduled for curative-intent liver resection - Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73 m² - Ability to understand the nature and implications of the clinical trial - Written informed consent

Exclusion criteria

Exclusion criteria: - American Society of Anesthesiologists (ASA) physical status =4 - Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide - Manifest hyperthyroidism or autonomous thyroid disease - Severe renal impairment (eGFR <30 mL/min/1.73 m²) - Previous severe hypersensitivity or anaphylactic reaction following ICG administration - Pregnancy or breastfeeding - Severe cognitive impairment or inability to provide informed consent - Expected lack of compliance with study procedures

Design outcomes

Primary

Measure	Time frame
• Intraoperative detection rate of CRLM, defined as the total number of histologically confirmed metastases resected per patient, including additional lesions identified intraoperatively that were not seen on preoperative imaging. • R0 resection rate, defined as the proportion of resected CRLMs with histologically confirmed tumor-free margins =1 mm	—

Secondary

Measure	Time frame
• Change in surgical strategy • Operating time • Intraoperative blood loss • Intraoperative blood transfusion requirements • Surgical approach (laparoscopic or robotic) • Conversion to open surgery • Type and extent of liver resection • IWATE difficulty score • Length of hospital stay • Length of intermediate care unit (IMC) and intensive care unit (ICU) stay • Postoperative morbidity • Reoperation rate • Postoperative invasive interventions • 90-day mortality • Time to recurrence • Site of recurrence • 1-, 3-, and 5-year overall survival (OS) • 1-, 3-, and 5-year disease-free survival (DFS)	—

Measure

Time frame

• Change in surgical strategy • Operating time • Intraoperative blood loss • Intraoperative blood transfusion requirements • Surgical approach (laparoscopic or robotic) • Conversion to open surgery • Type and extent of liver resection • IWATE difficulty score • Length of hospital stay • Length of intermediate care unit (IMC) and intensive care unit (ICU) stay • Postoperative morbidity • Reoperation rate • Postoperative invasive interventions • 90-day mortality • Time to recurrence • Site of recurrence • 1-, 3-, and 5-year overall survival (OS) • 1-, 3-, and 5-year disease-free survival (DFS)

—

Countries

Germany

Contacts

Public ContactSchaima Abdelhadi

Chirurgische Klinik der Universitätsmedizin Mannheim

schaima.abdelhadi@umm.de+496213832225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026