Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer

NCT02311543 | Completed Phase 3 DMC

• 1 other identifier: SAKK 23/13
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 16

Brief Summary

Axillary lymph node dissection remains an integral part of surgical treatment of primarily node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant seroma, a suction drain is routinely placed into the axillary cavity after axillary lymph node dissection (ALND) by a separate stab incision. The pathogenesis of seroma involves the collection of lymph fluid caused by dissection of lymph vessels and exudate. All coagulation and fibrinolytic factors are produced and secreted by lymphatic endothelial cells and are involved in the sealing of lymphatic capillaries. Local hemostyptic agents may therefore reduce postoperative secretion from lymphatic fistulas caused by ALND. We propose to conduct a multicenter prospective randomized control trial in Switzerland to evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of an equine collagen sponge coated with human fibrinogen and human thrombin) on axillary drainage after ALND for breast cancer. We hypothesize that the use of TachoSil® significantly and relevantly reduces the volume and duration of axillary drainage after ALND. This has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and reduce hospital costs.

Conditions

Breast Cancer

Keywords

Axillary Lymph Node Dissection (ALND); Breast Cancer; TachoSil®; Lymphatic Drainage; Surgical Sealing Patch

Outcome Measures

Primary Outcomes (1)

• Total volume of axillary drainage

  Total volume of axillary drainage in ml until drain removal.

  until drain removal (2 - 10 days after surgery)

Secondary Outcomes (6)

• Volume of axillary drainage per 24 hours

  until drain removal (2 - 10 days after surgery)

• Total duration of axillary drainage in days

  until drain removal (2 - 10 days after surgery)

• Duration of postoperative hospital stay in days

  between 3-6 days after surgery

• Patients with clinically relevant seroma

  until 24 weeks after surgery

• Number of clinically relevant seroma aspirations

  until 24 weeks after surgery

Study Arms (2)

Arm A: no TachoSil®

NO INTERVENTION

After axillary lymph node dissection no surgical sealing patch (TachoSil®) is applied.

Arm B: TachoSil®

ACTIVE COMPARATOR

After axillary lymph node dissection, 3 large TachoSil® patches in the dissected axilla are positioned to cover as much of the axillary walls as possible.

Drug: TachoSil® patches

Interventions

TachoSil® patches DRUG

TachoSil® is a sterile, ready-to-use, absorbable surgical patch and consists of an equine collagen sponge coated with human fibrinogen and human thrombin.

Arm B: TachoSil®

Eligibility Criteria

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

You may qualify if:

• at registration
• Patient has given written informed consent before registration
• Female patients; eligible for primary ALND or sentinel lymph node procedure with frozen section and either:
• newly diagnosed
• or recurrent breast cancer in the conserved breast, chest wall or axilla
• Patients with histo- or cytology proven breast cancer UICC/AJCC stage I-III
• Age ≥ 18 years
• Fluency in either German, French, Italian, Spanish, Turkish or English
• The EQ-5D questionnaire has been completed at registration
• Patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
• \- ALND indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery

You may not qualify if:

• Known hypersensitivity for TachoSil® or fibrin sealant
• Patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. If the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
• Prior axillary dissection (except prior sentinel node procedure)
• Prior axillary radiotherapy
• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms
• Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (16)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

CSSI Bellinzona/Lugano, Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Brustzentrum, Klinik Engeried

Bern, 3012, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Spital Thurgau AG, Brustzentrum

Frauenfeld, 8501, Switzerland

Location

Hôpitaux universitaires de Genève

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

Location

Tumor- und Brustzentrum ZeTuP St. Gallen

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

CHVC Hôpital de Sion

Sion, 1951, Switzerland

Location

Kantonsspital Winterthur, Brustzentrum

Winterthur, 8401, Switzerland

Location

Brust-Zentrum Seefeld

Zurich, 8008, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

UniversitätsSpital Zürich, Klinik für Gynäkologie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Weber WP, Tausch C, Hayoz S, Fehr MK, Ribi K, Hawle H, Lupatsch JE, Matter-Walstra K, Chiesa F, Dedes KJ, Berclaz G, Lelievre L, Hess T, Guth U, Pioch V, Sarlos D, Leo C, Canonica C, Gabriel N, Zeindler J, Cassoly E, Andrieu C, Soysal SD, Ruhstaller T, Fehr PM, Knauer M; Swiss Group for Clinical Cancer Research (SAKK). Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial. Ann Surg Oncol. 2018 Sep;25(9):2632-2640. doi: 10.1245/s10434-018-6556-9. Epub 2018 Jun 8.

  PMID: 29948418 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Walter Weber, MD

  University of Basel

  STUDY CHAIR

• Christoph Tausch, MD

  Klinik Hirslanden, Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: March 18, 2015
• Primary Completion: May 23, 2017
• Study Completion: June 27, 2017
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (16)