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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pituitary Adenoma

Interventions

Total resectionPROCEDURE

Total resection of HIPA in a single surgery

Staged resectionPROCEDURE

HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date

Subtotal resection followed by stereotactic radiation therapyPROCEDURE

HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of QoL (Quality of Life, EQ-5D) for the first surgery

EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years

Time frame: baseline (before the first surgery), 2 years after the first surgery

Change of QoL (Quality of Life, EQ-5D) for the second intervention

EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months

Time frame: baseline (before the second intervention), 3 months after the second intervention

Secondary Outcomes

Change of Visual Acuity statue

Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years

Time frame: baseline (before the first surgery), 2 years after the first surgery

Change of Visual Field statue

Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years

Time frame: baseline (before the first surgery), 2 years after the first surgery

Change of Hormone Replacement Therapy

Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years

Time frame: baseline (before the first surgery), 2 years after the first surgery

Extent of resection

Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.

Central Contacts

Tao Huang, PhD, MD

CONTACT

027-85350819 neuroht@hust.edu.cn

Data from ClinicalTrials.gov

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