Indocyanine Green for Perfusion Assessment of DIEP Flaps

NCT05507710 | Unknown Phase 3

• 1 other identifier: NL 68623.058.18
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.

Conditions

Fat Necrosis

Keywords

Fat necrosis; Near-infrared fluorescence imaging; Indocyanine green; Free flap surgery; Breast reconstruction; Perfusion

Outcome Measures

Primary Outcomes (1)

• Clinical relevant fat necrosis

  Clinically relevant fat necrosis is defined as a palpable mass, either painful or not, and with or without aesthetic complaints, and developed within three months after surgery. The following grading system according to Lie et al. is used. Only grade III till IV is classified as clinical relevant fat necrosis. III: Major compromised reconstructive outcome, flap involvement:15-50%, clinical findings: Major contour defects (multiple), surgical management: Debridement/secondary procedure IV: Subtotal poor reconstructive outcome, flap involvement: \>50%, clinical findings: Skin defects, inadequate volume, volume loss, surgical management: Second local flap/ re-intervention initial flap

  3 months

Secondary Outcomes (7)

• Quantify perfusion of flaps

  3 months

• Registration of re-interventions

  3 months

• Registration of postoperative complications

  3 months

• Duration of surgery in minutes

  1 day

• Percentage extra resected tissue

  1 day

Study Arms (2)

Interventional study arm

ACTIVE COMPARATOR

Surgery will be performed according to local protocol. Flap viability during adequate hemodynamic conditions is evaluated a standard of care. Then after anastomosis of the flap but before the inset, the second intervention is performed. Intervention: evaluation of the perfusion of the skin and fat with fluorescence imaging using ICG. The flap is marked according to the fluorescence imaging evaluation, and parts without perfusion are resected. The remaining flap is inset to the remaining breast skin.

Diagnostic Test: Near-infrared fluorescence imaging of perfusion

Control arm

NO INTERVENTION

Surgery will be performed according to local protocol.Flap viability during adequate hemodynamic conditions is evaluated as standard of care. Then after anastomosis of the flap but before the inset, the surgeon will leave the room, the researcher will make a recording of the flap and this will have no consequences for the procedure.

Interventions

Near-infrared fluorescence imaging of perfusion DIAGNOSTIC_TEST

Imaging with ICG near-infrared fluorescence is performed besides clinical judgement of the DIEP flap for perfusion evaluation. Based on fluorescence imaging, additional malperfused area(s) are resected.

Interventional study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients 18 years of age and older
• Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition
• Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps. In case of bilateral breast reconstruction the flaps should be bilateral anastomosed.
• Written informed consent

You may not qualify if:

• Allergy to ICG, iodine or shellfish
• Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
• Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 (this can be seen in the standard preoperative lab results)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

Related Publications (1)

• Tange FP, Verduijn PS, Sibinga Mulder BG, van Capelle L, Koning S, Driessen C, Mureau MAM, Vahrmeijer AL, van der Vorst JR. Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial. Contemp Clin Trials Commun. 2023 Apr 2;33:101128. doi: 10.1016/j.conctc.2023.101128. eCollection 2023 Jun.

  PMID: 37091505 DERIVED

MeSH Terms

Conditions

Fat Necrosis

Condition Hierarchy (Ancestors)

Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander L. Vahrmeijer, MD, PhD

CONTACT

+31 71 526 2309; a.l.vahrmeijer@lumc.nl

Pieter S. Verduijn, MD

CONTACT

0715296212; P.S.Verduijn@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant is blinded for the study arm. A second evaluator of postinterventional fat necrosis is blinded for the study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologic Surgeon - Hepatobiliary and Colorectal

Model Details: This is a two-armed randomized controlled trial: * interventional arm: evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG * conventional arm: evaluation of flap perfusion based on clinical parameters only

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: May 1, 2019
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)