Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Primary Purpose
Pituitary Adenoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total resection
Staged resection
Subtotal resection followed by stereotactic radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Adenoma focused on measuring pituitary adenoma, treatment strategy, Hypothalamus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HIPA group of Puget grade 1
HIPA group of Puget grade 2
Arm Description
the tumor abuting or displacing the hypothalamus in the preoperative MR images
hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
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.
Full Information
NCT ID
NCT04863456
First Posted
March 29, 2021
Last Updated
April 27, 2021
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04863456
Brief Title
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Official Title
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
Keywords
pituitary adenoma, treatment strategy, Hypothalamus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIPA group of Puget grade 1
Arm Type
Experimental
Arm Description
the tumor abuting or displacing the hypothalamus in the preoperative MR images
Arm Title
HIPA group of Puget grade 2
Arm Type
Experimental
Arm Description
hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images
Intervention Type
Procedure
Intervention Name(s)
Total resection
Intervention Description
Total resection of HIPA in a single surgery
Intervention Type
Procedure
Intervention Name(s)
Staged resection
Intervention Description
HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date
Intervention Type
Procedure
Intervention Name(s)
Subtotal resection followed by stereotactic radiation therapy
Intervention Description
HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy
Primary Outcome Measure Information:
Title
Change of QoL (Quality of Life, EQ-5D) for the first surgery
Description
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
Title
Change of QoL (Quality of Life, EQ-5D) for the second intervention
Description
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 Outcome Measure Information:
Title
Change of Visual Acuity statue
Description
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
Title
Change of Visual Field statue
Description
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
Title
Change of Hormone Replacement Therapy
Description
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
Title
Extent of resection
Description
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.
Time Frame
baseline (before the first surgery), 2 years after the first surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Huang, PhD, MD
Phone
027-85350819
Email
neuroht@hust.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Huang, PhD, MD
Organizational Affiliation
Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
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