NCT00993356

Brief Summary

Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. The investigators also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

5.9 years

First QC Date

October 9, 2009

Last Update Submit

October 9, 2009

Conditions

Acromegaly

Keywords

AcromegalyMacroadenomasLanreotideTranssphenoidal neurosurgeryPreoperative

Outcome Measures

Primary Outcomes (1)

  • Cure rate at evaluation 4 months postoperatively

    every 4 weeks

Secondary Outcomes (1)

  • Postoperative hospital stay duration

    every 4 weeks

Study Arms (2)

Group 2

OTHER

After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group).

Procedure: Transsphenoidal surgery

Group 1

EXPERIMENTAL

Patients received lanreotide for 16 weeks before the surgical resection \[starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH \> 5 mU/L on GH day curve (GHDC)\] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).

Drug: Preoperative lanreotide treatment

Interventions

Preoperative lanreotide treatmentDRUG

Patients received lanreotide for 16 weeks before the surgical resection \[starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH \> 5 mU/L on GH day curve (GHDC)\] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).

Group 1
Transsphenoidal surgeryPROCEDURE
Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with newly diagnosed acromegaly due to GH-secreting macro-adenomas.
  • newly diagnosed, previously untreated patients with GH nadir more than 2.5 μg/L during a standard 75-g, 2-h oral glucose tolerance test (OGTT)
  • pituitary macroadenomas (maximum diameter \>1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan
  • age between 18 and 80 yr.

You may not qualify if:

  • immediate surgery indicated by clinical criteria
  • pregnancy
  • contraindications to MRI scan
  • patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (2)

  • Mao ZG, He DS, Zhou J, Yao B, Xiao WW, Chen CH, Zhu YH, Wang HJ. Differential expression of microRNAs in GH-secreting pituitary adenomas. Diagn Pathol. 2010 Dec 7;5:79. doi: 10.1186/1746-1596-5-79.

    PMID: 21138567DERIVED

  • Mao ZG, Zhu YH, Tang HL, Wang DY, Zhou J, He DS, Lan H, Luo BN, Wang HJ. Preoperative lanreotide treatment in acromegalic patients with macroadenomas increases short-term postoperative cure rates: a prospective, randomised trial. Eur J Endocrinol. 2010 Apr;162(4):661-6. doi: 10.1530/EJE-09-0908. Epub 2010 Jan 8.

    PMID: 20061334DERIVED

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Hai-jun Wang, MD

    Department of Neurosurgery, The First Affiliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Hai-jun Wang, MD

CONTACT

+86-20-88233388drhaijun.wang@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

January 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

CN(1)