BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.

NCT ID: NCT05373069

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-05-31

Brief Summary

Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast cancer is around 85%. Surgical treatment by total mastectomy concerns around 30% of cases. For patients who have been treated for breast cancer by total mastectomy, secondary breast reconstructions are often carried out via excess abdominal fat flaps of DIEP type.

Postoperative partial fat necrosis is a common complication of breast reconstruction. This necrosis is qualified as pathological when it is palpable or when there are symptoms leading to pain, deformation, or leakage. Necrosis occurs in the first 6 months after surgery. Diagnosis is carried out by the detection of a nodule of fat necrosis measuring at least 5 mm on the ultrasound.

Partial flat necrosis results from ischemia reperfusion (IR) to the fat tissues during reconstruction. IR leads to inflammatory lesions, edema, capillary occlusion that can lead to tissue necrosis. The deleterious impact of IR has been shown on the organs (liver, kidney) on muscular, cutaneous and adipose tissues in humans and animals.

Ischaemic preconditioning is a procedure used in organ transplant surgery, allowing a better tolerance of the graft for ischemia reperfusion, without further complications. It is used in usual practice for kidney or liver transplants; short cycles of ischemia reperfusion are carried out on the organ pedicle before harvesting using cold ischemia (out of the donor's body) pre-transplant.

Ischaemic preconditioning before reconstruction has been studied in animal models but not in human reconstruction surgery, although it seems to be beneficial. For patients undergoing total mastectomy after being diagnosed with breast cancer, we hypothesize that ischaemic preconditioning, usually used for organ transplants, could decrease adipose tissue lesions caused by ischemia reperfusion after breast reconstruction with DIEP (deep inferior epigastric perforator) flaps.

Detailed Description

This is a phase 2 monocentric study, following the 2 step Simon Minimax design.

We will be carrying out cycles of ischemic preconditioning for 40 minutes, simulating 2 cycles of ischemia-reperfusion (per 10min) prior to flap harvesting and cold ischemia before revascularization.

The pre operation visit will occur between M3 and M1 before the scheduled operation date. The visit will be carried out by the surgeon who will inform the patient of the study.

The inclusion visit (D0) will be carried out by the investigator the day before surgery (collection of signed consent form). The surgery will be carried out as usual: breast reconstruction with DIEP type flap. Modification of the intervention for the study: preconditioning of the flap (for patients) and 3 biopsies.

During post-operative hospitalization, usual visits will be carried out twice a day (not specifically for the study) by an doctor (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation).

After postoperative discharge, 4 follow up visits are planned which correspond to 3 postoperative consultations at the hospital (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation) at D21 (+/- 2 days), M1 (+/- 2 days), M3 (+/- 15 days, same assessment plus search for palpable, painful or deforming nodules) and M6 (+/- 15 days, last visit) plus a mammary ultrasound (this is the only supplementary assessment carried out for the study, Tenon hospital).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group intervention

PIM - DIEP

Group Type: EXPERIMENTAL

Mechanical ischemic preconditioning of diep-type flap

Intervention Type: PROCEDURE

Mechanical ischemic preconditioning: Performing series of reperfusion ischemia on the flap pedicle, before cold ischemia of the flap (flap harvesting before vascular mechanical anastomoses at the recipient site)

• 10 min of clamping with single-use microvascular forceps
• 10 min declamping
• 10 min of tightening with pliers
• 10 min declamping Either preconditioning for 40 minutes, simulating 2 cycles of ischemia reperfusion prior to flap harvesting and cold ischemia before revascularization.

Interventions

Mechanical ischemic preconditioning of diep-type flap

Mechanical ischemic preconditioning: Performing series of reperfusion ischemia on the flap pedicle, before cold ischemia of the flap (flap harvesting before vascular mechanical anastomoses at the recipient site)

• 10 min of clamping with single-use microvascular forceps
• 10 min declamping
• 10 min of tightening with pliers
• 10 min declamping Either preconditioning for 40 minutes, simulating 2 cycles of ischemia reperfusion prior to flap harvesting and cold ischemia before revascularization.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• female with age ≥ 18
• Secondary unilateral breast reconstruction using DIEP
• Signed consent form
• Beneficiary of a social security scheme

Exclusion Criteria

• Smoking: active or quit since < 2 months, contraindication for flap surgery
• Pregnancy: contraindication for surgery
• Immediate breast reconstruction, at the same time as the mastectomy (increases cutaneous complications and different surgical technique)
• Bilateral breast reconstruction (increases operation time and post operation complications)
• Patient under curatorship or guardianship
• Patient deprived of their liberty, and patient undergoing psychiatric care
• Risk factor for DIEP complication such as: previous surgical procedures performed on the abdomen, carcinological treatments and severe comorbidities of the patient.
• Risk factors for complications of mechanical preconditioning. Soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis,
• Participation in another interventional study
• Any contraindication to general anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

INSERM Bichat hospital

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarra CRISTOFARI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service Plastique, Reconstruction, Esthétique, Hôpital TENON- APHP

Paris, , France

Countries

France

Central Contacts

Sarra CRISTOFARI, MD, PhD

Role: CONTACT

sarra.cristofari@gmail.com

+33 6 30 33 39 56

Michael ATLAN, PU-PH

Role: CONTACT

drmichaelatlan@gmail.com

0156017000

Facility Contacts

Sara CRISTOFARI, MD, PhD

Role: primary

sarra.cristofari@gmail.com

+33 6 30 33 39 56

Michael ATLAN, PU-PH

Role: backup

drmichaelatlan@gmail.com

0156017000

Other Identifiers

2021-A00173-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP201173

Identifier Type: -

Identifier Source: org_study_id