Clinical trial NCT05327309: Role of Propranolol as Compared to Bleomycin in Management of Hemangioma
Official title: Role of Propranolol as Compared to Bleomycin in Management of Hemangioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemangioma
Propranolol
Keywords: Infantile Cutaneous hemangioma
Propranolol treatment
Bleomycin treatment
Efficacy
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infantile hemangiomas are widespread vascular tumours having incidence of 10% and most of them involute spontaneously. However, they are known to be located in proximity of vital organs and can have poor cosmetic and functional sequel if left untreated. A wide range of treatment options are available from expectant therapy to radical surgical excision. Propanolol has also been shown to be effective in treating infantile cutaneous hemangiomas. Similarly, anti-metabolite drugs as bleomycin has also shown promising results. Efficacy in terms of reduction in size of both treatments has been scarcely studied especially in Pakistan.

OBJECTIVE: To assess the efficacy of oral propranolol and intraleisonal bleomycin in the treatment of infantile cutaneous hemangioma in terms of size regression

Detailed description: Material \& Methods Study design: Randomised controlled trial Place of study: This is study was conducted in the department of paediatric surgery, children hospital, Pakistan institute of medical sciences, Islamabad Duration of study: 24 months

Number of patients:

Using the WHO sample size calculator with following statistical assumptions Confidence interval = 90% Alpha errors = 5% Anticipated population proportion in Group A = 85%9 Anticipated population proportion in Group B = 62.5%9 Sample size will be 45 cases in each study group. Total number of 90 cases will be required in this study Sampling technique: Probability sampling technique Sélection criteria Inclusion criteria

1. 6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body 2. Both sex included 3. Previously not treated Exclusion criteria On the basis of history and clinical assessment;

1. Patients with previous treatment of hemangioma.
2. Patients who will be lost to follow up
3. Patients who refused to be enrolled in this study
4. Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or had previous known allergy to the drugs.
5. Patients who had diagnosed Cardiac disease such as heart failure or AV block.
6. Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.
7. History of impaired renal or liver functions.
8. Diabetes mellitus Collection procedure After approval of synopsis, researcher collected data after taking permission from hospital Ethical Committee. Patients were entertained through outdoor department. Patient was explained about the whole procedure. Brief history and clinical examination and investigations were recorded on a Performa. The patients who were diagnosed cases of any cardiac, pulmonary, renal or hepatic diseases were excluded from study based on history. Diagnosis was established on clinical grounds and Doppler ultrasonography of the hemangioma were done to confirm the diagnosis if needed. Size of hemangioma taken and any skin changes were noted.

Patients were explained about the whole treatment and informed written consent taken.

Number of patients: It was conducted on 90 patients that were divided in equal number to two groups randomly by lottery system.

Group A: Included those who had to be managed with oral propranolol. Group B: included those who had to be managed with intralesional injection bleomycin.

The patients were seen in OPD and followed up in OPD. Patients were randomly divided into two non biased groups. One group i.e. Group A received propranolol with a mean dose of 2mg/kg/day in 2 divided doses for a period of 6 months.

Group B consisted of those who received Bleomycin 15mg diluted in 15 ml of 2% plain lidocaine along with a dosage of 0.5 mg/kg for a period of 6 months. The dose of lidocaine was 3mg/kg. It was injected intralesionaly using a syringe and a 27-gauge. Where needed, a pressure dressing was applied for 24 hours. A total of 6 injections were administered and the interval between injections was 2-4 weeks. The patients were admitted for 24 hrs in ward after General Anesthesia (GA) whereas, if GA was not given patient was monitored in day care. Dosage of bleomycin and nature of anaesthesia (i.e., general anaesthetic, local anaesthetic with or without sedation) were prospectively recorded for every patient and session. Vitals were checked in first 24hr period in both groups and noted. Those patient who exhibited any signs of hypersensitivity during and after administration were also left out.

Follow up were done weekly for 1 month in both groups to see changes in size and skin in both groups. After that the follow up was on monthly basis till 6 months. In each visit patients had full clinical examination including pulse and blood pressure with recording of dimensions of the hemangioma based on direct measurement (in centimetres and length, width, height measurement).Small hemangiomas were measured using vernier calliper and others with measuring scale.

Data was collected on follow up for both groups to confirm regression in size of hemangiomas and complications were noted. Single observer (resident pediatrician) saw the patients in each follow up and final outcome measured at 6th month. All this data was recorded on a Performa from 1st month to 6th month on monthly basis.

Statically analysis Data was analyzed by using statistical package for social sciences (SPSS) version 23.0. Mean and standard deviation was calculated for qualitative variables like age, size at the baseline and at the follow up visit up till 6 month.

Frequency and percentages were presented for qualitative data (sex, efficacy in terms of size of hemangioma). Chi square test was applied to compare efficacy of hemangioma in both groups at each visit. A P value \< 0.05 was considered statistically significant. Effect modifiers like age, gender, duration and size of hemangioma were controlled by stratification.

Eligibility criteria: Inclusion Criteria:

* 1. 6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body 2. Both sex included 3. Previously not treated

Exclusion Criteria:

On the basis of history and clinical assessment;

1. Patients with previous treatment of hemangioma.
2. Patients who will be lost to follow up
3. Patients who refused to be enrolled in this study
4. Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or had previous known allergy to the drugs.
5. Patients who had diagnosed Cardiac disease such as heart failure or AV block.
6. Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.
7. History of impaired renal or liver functions.
8. Diabetes mellitus

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Primary outcomes:
measure: Size change
timeFrame: 02 years
measure: Size Regression Efficacy Complications:
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Thayal PK, Bhandari PS, Sarin YK. Comparison of efficacy of intralesional bleomycin and oral propanolol in management of hemangiomas. Plast Reconstr Surg. 2012 Apr;129(4):733e-735e. doi: 10.1097/PRS.0b013e318245e739. No abstract available.