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

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

Detailed Description
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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.

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

Conditions
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Pituitary Adenoma

Intervention / Treatment
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* Procedure: Total resection
* Procedure: Staged resection
* Procedure: Subtotal resection followed by stereotactic radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPA group of Puget grade 1<br>the tumor abuting or displacing the hypothalamus in the preoperative MR images | Procedure: Total resection<br>* Total resection of HIPA in a single surgery<br>Procedure: Staged resection<br>* HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date<br>Procedure: Subtotal resection followed by stereotactic radiation therapy<br>* HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy<br>|
| Experimental: HIPA group of Puget grade 2<br>hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images | Procedure: Total resection<br>* Total resection of HIPA in a single surgery<br>Procedure: Staged resection<br>* HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date<br>Procedure: Subtotal resection followed by stereotactic radiation therapy<br>* HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline (before the second intervention), 3 months after the second intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | baseline (before the first surgery), 2 years after the first surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pituitary adenoma, treatment strategy, Hypothalamus