Trial · NCT06943703
Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma
NCT06943703, Completed, National Children's Hospital, Vietnam
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma. Trials, record NCT06943703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06943703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma
- NCT number
- NCT06943703
- Status
- Completed
- Enrollment
- 809 participants, actual
- Lead sponsor
- National Children's Hospital, Vietnam
- Conditions
- Lymphangioma, Lymphatic Malformations
- Interventions
- Sclerotherapy with intralesional bleomycin injection
- First posted
- 2025-04-24
- Last updated
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Lesion Size | Through study completion, an average of 5 years | The degree of lesion size change will be measured to assess the efficacy of intralesional Bleomycin injection. This will be evaluated through clinical examination and imaging techniques (e.g., ultrasound or MRI) to determine the extent of regression of the lymphangioma. |
| Primary | Recurrence Rate | Through study completion, an average of 5 years | This outcome will track the recurrence rate of lymphangiomas after treatment with Bleomycin. Recurrence is defined as the reappearance or regrowth of the lesion after an initial reduction in size following treatment. |
| Primary | Adverse Reactions | 1 week after each injection | The safety of the Bleomycin treatment will be assessed by monitoring adverse reactions, including infection, bleeding, swelling, or allergic reactions at the injection site, as well as any systemic side effects. |
| Primary | Number of Injections Required for Remission | Through study completion, an average of 5 years | The number of Bleomycin injections required to achieve remission (defined as significant size reduction or complete resolution of the lesion) will be recorded. This will help assess the treatment protocol's efficiency and the typical treatment burden for patients. |
| Primary | Proportion of patients requiring additional interventions | Through study completion, an average of 5 years | This outcome will track the proportion of patients requiring additional interventions (e.g., surgical excision or further sclerotherapy sessions) after the initial Bleomycin treatment. The goal is to determine if Bleomycin alone is sufficient to treat the lymphangiomas or if supplementary interventions are necessary. |
| Primary | PSAQ score - Cosmetic Outcomes and Scar Perception | Through study completion, an average of 5 years | Cosmetic outcomes and patient scar perception were evaluated using the Patient Scar Assessment Questionnaire (PSAQ). This validated tool includes multiple subscales assessing appearance, symptoms, consciousness, and satisfaction with appearance. Each subscale is scored on a 4-point Likert scale, with individual item scores ranging from 1 to 4, where lower scores indicate better cosmetic outcomes and greater patient satisfaction. The minimum total score is 18, and the maximum is 72, with lower total scores representing more favorable scar outcomes. |
| Primary | SF-36 score - Health-Related Quality of Life (QoL) | Through study completion, an average of 5 years | Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), a validated instrument comprising 36 items across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health perceptions. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Both individual domain scores and composite physical and mental component summary scores were analyzed. |
| Secondary | Follow-Up Time | Through study completion, an average of 5 years | The duration of follow-up visits post-treatment will be tracked to monitor for recurrence or complications. Follow-up time will also help assess the long-term effectiveness of Bleomycin treatment. |
| Secondary | Time to Regrowth of Lesion | Through study completion, an average of 5 years | This outcome will measure the time to regrowth of the lymphangioma lesion after initial Bleomycin treatment. The time period between treatment and the first signs of regrowth will be monitored to evaluate the durability of the treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06943703
GET https://conductscience.org/api/trials/v1/NCT06943703/registered