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

Phase 4

• Conditions: Acromegaly
• Interventions: Drug: Sandostatin (Octreotide Acetate)

• Registration Number: NCT02427295
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed 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)

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-02-04
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-22
• Last Update Submitted: 2015-04-22
• Study First Posted: 2015-04-28
• Last Update Posted: 2015-04-28
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Surgery + Medical treatment	Sandostatin (Octreotide Acetate)	MRI : residual tumor 6 months post-op : IGF-1 \>600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)

Primary Outcome Measures

Name	Time	Method
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)	Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative
The time taken to IGF-1 normalization in each group.	Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative

Secondary Outcome Measures

Name	Time	Method
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose	Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative
Clinical symptom and sign with AcroQoL questionnaire	Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
Sleep quality and disturbance with written questionnaire	Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
fasting glucose , postprandial glucose	Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
HbA1c	change from pre-operative in HbA1c at 36 months post-operative.
insulin	Change from pre-operative in insulin at 36 months post-operative.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of