Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues (acromegaly)

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Acromegaly

Treatments: Drug: Sandostatin (Octreotide Acetate)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02427295

CSMS995BKR08T

Details and patient eligibility

About

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

Full description

Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited.

The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older.

• Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15
• Number of Centers: 1 (single center)

Enrollment: 1 estimated patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or older.
2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features.
3. No prior use of somatostatin analogues.
4. Adequate hepatic and renal function
5. Provision of a signed written informed consent

Exclusion criteria

1. Severe co-morbid illness such as untreatable other malignancy and/or active infections.
2. Pregnant or lactating women
3. Hypersensitivity to Sandostatin or any component of the formulation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Group 2: Surgery + Medical treatment

Experimental group

Description:

MRI : residual tumor 6 months post-op : IGF-1 \>600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)

Treatment:

Drug: Sandostatin (Octreotide Acetate)

Group 3 : Rescue group

No Intervention group

Description:

If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)

Gruop1 : Surgery only group

No Intervention group

Description:

MRI : without residual tumor 6months post-operation and IGF-1 \<600ng/ml