Postmastectomy Lymphedema SyndromeNCT03559296
Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade
An observational study of Postmastectomy Lymphedema Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postmastectomy Lymphedema Syndrome
- What is being tested?
- Ultrasonographic assessment of postmastectomy lymphedema
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 13 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Women with postmastectomy lymphedema aged 18-65 years old
Who may be able to join
- 1. Patients with unilateral postmastectomy lymphedema
Who cannot join
- Bilateral lymphedema
- The patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: The Inter- and Intra-rater Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade in Postmastectomy Lymphedema
The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema.
Read the detailed description
The clinical severity of lymphedema in an extremity is generally graded according to the International Society of Lymphology (ISL) stage. Stage 0 which refers to a latent or subclinical condition where swelling is not evident despite impaired lymph transport. It may exist months or years before overt edema occurs (Stages I-III). Stage I represents an early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) and subsides with limb elevation. Pitting may occur. Stage II signifies that limb elevation alone rarely reduces tissue swelling and pitting is manifest. Late in Stage II, the limb may or may not pit as tissue fibrosis supervenes. Stage III encompasses lymphostatic elephantiasis where pitting is absent and trophic skin changes such as acanthosis, fat deposits, and warty overgrowths develop. Within each Stage, severity based on volume difference can be assessed as minimal (<20% increase) in limb volume, moderate (20-40% increase), or severe (>40% increase).
Because the ISL stage mainly consists of findings achieved by physical examinations and represents the most severely affected arm, it is subjective and may not reflect the distribution and mode of progression of the disease. The characteristic skin and subcutaneous tissue changes in extremities with chronic lymphedema are caused by changes in the extracellular matrix, such as connective tissue hypertrophy, fat accumulation resulting from both fat hypertrophy and an increased number of adipocytes, and interstitial protein-rich fluid accumulation. Ultrasound has been used to assess and diagnose lymphedema related changes. Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema are developed in order to grade lymphedema objectively and to delineate the disease status more clearly. However, the reliability of SEG and SEFS has not been evaluated. The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema. Two physiatrist (one ten-year-experienced and one five-year-experienced in musculoskeletal ultrasonography) independently and alternately will assess the subjects once for each assessment. Three days later after the initial examination, one of the physiatrists reassessed the patients. The inter- and intra-rater reliability will be determined using kappa.
- Conditions
- Postmastectomy Lymphedema Syndrome
- Being tested
- Ultrasonographic assessment of postmastectomy lymphedema
- Keywords
- imaging, assessment, edema, dermis, postmastectomy Lymphedema, reliability, ultrasound, grade
- Medical subject headings
- Edema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic assessment of postmastectomy lymphedemaDiagnostic test
Qualitative assessment of postmastectomy lymphedema via ultrasound (Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema) and circumferential tape measures ( The circumferential measurement of affected arm at MCP joint, wrist joint, 15 below elbow joint, elbow joint 15cm above elbow point) to assess upper extremity volume
| Study group | Role | What they receive |
|---|---|---|
| Study Group | patients with postmastectomy lymphedema who will undergo ultrasonographic assessment of postmastectomy lymphedema and circumferential tape measurement of arm Receives: Diagnostic Test: Ultrasonographic assessment of postmastectomy lymphedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Society of Lymphology (ISL) stage by rater 1
stage of the clinical severity of lymphedema
Measured: Day 0
International Society of Lymphology (ISL) stage by rater 1
stage of the clinical severity of lymphedema
Measured: Day 3
International Society of Lymphology (ISL) stage by rater 2
stage of the clinical severity of lymphedema
Measured: Day 0
Secondary outcomes (18)
MCP joint level affected arm
The circumferential measurement of affected arm at the metacarpophalangeal joints (MCP)
Measured: Day 0
MCP joint level unaffected arm
The circumferential measurement of affected arm at the MCP joints
Measured: Day 0
wrist joint level affected arm
The circumferential measurement of affected arm at wrist joint
Measured: Day 0
wrist joint level unaffected arm
The circumferential measurement of affected arm at wrist joint
Measured: Day 0
15 cm below the elbow joint point affected arm
The circumferential measurement of affected arm at 15 cm below the elbow joint point
Measured: Day 0
15 cm below the elbow joint point unaffected arm
The circumferential measurement of affected arm at 15 cm below the elbow joint point
Measured: Day 0
elbow joint point affected arm
The circumferential measurement of affected arm at the elbow joint point
Measured: Day 0
elbow joint point unaffected arm
The circumferential measurement of unaffected arm at the elbow joint point
Measured: Day 0
15 cm above the elbow joint point affected arm
The circumferential measurement of affected arm at 15 cm above the elbow joint point
Measured: Day 0
15 cm above the elbow joint point unaffected arm
The circumferential measurement of affected arm at 15 cm above the elbow joint point
Measured: Day 0
Affected extremity volume (mL)
Lymphedema of the limbs were assessed by a single physiotherapist using the circumferential and volumetric methods before and after the treatment protocol. The circumferential upper limb measurements were carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) was used to convert these values into limb volumes in milliliters.
Measured: Day 0
Unaffected extremity volume (mL)
Lymphedema of the limbs were assessed by a single physiotherapist using the circumferential and volumetric methods before and after the treatment protocol. The circumferential upper limb measurements were carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) was used to convert these values into limb volumes in milliliters.
Measured: Day 0
Subcutaneous echogenicity (SEG) grade by rater 1
Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable
Measured: Day 0
Subcutaneous echogenicity (SEG) grade by rater 1
Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable
Measured: Day 3
Subcutaneous echogenicity (SEG) grade by rater 2
Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable
Measured: Day 0
Subcutaneous echo-free space (SEFS) grade by rater 1
Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Measured: Day 0
Subcutaneous echo-free space (SEFS) grade by rater 1
Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Measured: Day 3
Subcutaneous echo-free space (SEFS) grade by rater 2
Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jul 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmastectomy Lymphedema SyndromeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlker Yagci, Prof, Msc, Principal investigator, Marmara UniversityEsra Giray, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559296
- Sponsor's protocol ID
- 09.2018.466
- Status last verified
- Aug 2018
- First submitted
- 6 Jun 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't plan to share.
Publications
Giray E, Yagci I. Interrater and Intrarater Reliability of Subcutaneous Echogenicity Grade and Subcutaneous Echo-Free Space Grade in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2019 Oct;17(5):518-524. doi: 10.1089/lrb.2018.0053. Epub 2018 Dec 20.
PubMed 30570358
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inter- and Intra-rater Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade in Postmastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT03559296
- Acronym / sponsor ID
- 09.2018.466
- Conditions
- Postmastectomy Lymphedema Syndrome
- Keywords
- imaging, assessment, edema, dermis, postmastectomy Lymphedema, reliability, ultrasound, grade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema.
Detailed description
The clinical severity of lymphedema in an extremity is generally graded according to the International Society of Lymphology (ISL) stage. Stage 0 which refers to a latent or subclinical condition where swelling is not evident despite impaired lymph transport. It may exist months or years before overt edema occurs (Stages I-III). Stage I represents an early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) and subsides with limb elevation. Pitting may occur. Stage II signifies that limb elevation alone rarely reduces tissue swelling and pitting is manifest. Late in Stage II, the limb may or may not pit as tissue fibrosis supervenes. Stage III encompasses lymphostatic elephantiasis where pitting is absent and trophic skin changes such as acanthosis, fat deposits, and warty overgrowths develop. Within each Stage, severity based on volume difference can be assessed as minimal (<20% increase) in limb volume, moderate (20-40% increase), or severe (>40% increase).
Because the ISL stage mainly consists of findings achieved by physical examinations and represents the most severely affected arm, it is subjective and may not reflect the distribution and mode of progression of the disease. The characteristic skin and subcutaneous tissue changes in extremities with chronic lymphedema are caused by changes in the extracellular matrix, such as connective tissue hypertrophy, fat accumulation resulting from both fat hypertrophy and an increased number of adipocytes, and interstitial protein-rich fluid accumulation. Ultrasound has been used to assess and diagnose lymphedema related changes. Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema are developed in order to grade lymphedema objectively and to delineate the disease status more clearly. However, the reliability of SEG and SEFS has not been evaluated. The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema. Two physiatrist (one ten-year-experienced and one five-year-experienced in musculoskeletal ultrasonography) independently and alternately will assess the subjects once for each assessment. Three days later after the initial examination, one of the physiatrists reassessed the patients. The inter- and intra-rater reliability will be determined using kappa.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Ultrasonographic assessment of postmastectomy lymphedemapatients with postmastectomy lymphedema who will undergo ultrasonographic assessment of postmastectomy lymphedema and circumferential tape measurement of arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with postmastectomy lymphedema aged 18-65 years old
Key inclusion criteria (1 listed)
- 1. Patients with unilateral postmastectomy lymphedema
Key exclusion criteria (2 listed)
- Bilateral lymphedema
- The patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic assessment of postmastectomy lymphedemaQualitative assessment of postmastectomy lymphedema via ultrasound (Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema) and circumferential tape measures ( The circumferential measurement of affected arm at MCP joint, wrist joint, 15 below elbow joint, elbow joint 15cm above elbow point) to assess upper extremity volume | Diagnostic test | Study Group |
Primary outcome
International Society of Lymphology (ISL) stage by rater 1
Time frame: Day 0
stage of the clinical severity of lymphedema
International Society of Lymphology (ISL) stage by rater 1
Time frame: Day 3
stage of the clinical severity of lymphedema
International Society of Lymphology (ISL) stage by rater 2
Time frame: Day 0
stage of the clinical severity of lymphedema
18 secondary outcomes
MCP joint level affected arm
Time frame: Day 0
MCP joint level unaffected arm
Time frame: Day 0
wrist joint level affected arm
Time frame: Day 0
wrist joint level unaffected arm
Time frame: Day 0
15 cm below the elbow joint point affected arm
Time frame: Day 0
15 cm below the elbow joint point unaffected arm
Time frame: Day 0
elbow joint point affected arm
Time frame: Day 0
elbow joint point unaffected arm
Time frame: Day 0
15 cm above the elbow joint point affected arm
Time frame: Day 0
15 cm above the elbow joint point unaffected arm
Time frame: Day 0
Affected extremity volume (mL)
Time frame: Day 0
Unaffected extremity volume (mL)
Time frame: Day 0
Subcutaneous echogenicity (SEG) grade by rater 1
Time frame: Day 0
Subcutaneous echogenicity (SEG) grade by rater 1
Time frame: Day 3
Subcutaneous echogenicity (SEG) grade by rater 2
Time frame: Day 0
Subcutaneous echo-free space (SEFS) grade by rater 1
Time frame: Day 0
Subcutaneous echo-free space (SEFS) grade by rater 1
Time frame: Day 3
Subcutaneous echo-free space (SEFS) grade by rater 2
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Derived from this study: PubMed 30570358Giray E, Yagci I. Interrater and Intrarater Reliability of Subcutaneous Echogenicity Grade and Subcutaneous Echo-Free Space Grade in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2019 Oct;17(5):518-524. doi: 10.1089/lrb.2018.0053. Epub 2018 Dec 20.
- Individual participant dataSharing planned: No. We don't plan to share.
Related trials for Postmastectomy Lymphedema Syndrome
RecruitingObservational study
Deep Learning for Musculoskeletal Complications in Breast Cancer
Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain
Active, not recruiting
Lymphaticovenous Anastomosis as Treatment for Lymphedema
Breast Cancer Lymphedema, Secondary Lymphedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlker Yagci, Prof, Msc principal investigator
Marmara University
Esra Giray, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmastectomy Lymphedema Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Society of Lymphology (ISL) stage by rater 1 (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.