Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas

Status

Status unknown

Phase

Phase 2

Enrollment

96 participants (estimated)

Sponsor

Shanghai Jiao Tong University School of Medicine · Other

Design

Randomized · Open label (no masking)

Countries

1 country

China

Start

Jan 2004

Primary completion

Dec 2009 (estimated)

Completion

Dec 2010 (estimated)

First posted

12 Oct 2009 (estimated)

Last update posted

12 Oct 2009 (estimated)

Conditions

Acromegaly

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.

• Other

  Group 2

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

• Experimental

  Group 1

  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).

1. Cure rate at evaluation 4 months postoperatively

   Time frame · every 4 weeks