Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Pituitary Adenoma

Treatments: Procedure: Total resection; Procedure: Subtotal resection followed by stereotactic radiation therapy; Procedure: Staged resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04863456

[2021]IEC-J(227)

Details and patient eligibility

About

Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

Full description

There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement
• Informed consent

Exclusion criteria

• No follow-up possible
• Emergency surgery without informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

HIPA group of Puget grade 1

Experimental group

Description:

the tumor abuting or displacing the hypothalamus in the preoperative MR images

Treatment:

Procedure: Total resection

Procedure: Staged resection

Procedure: Subtotal resection followed by stereotactic radiation therapy

HIPA group of Puget grade 2

Experimental group

Description:

hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images

Treatment:

Procedure: Total resection

Procedure: Staged resection

Procedure: Subtotal resection followed by stereotactic radiation therapy