search
Back to results

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
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring pituitary adenoma, treatment strategy, Hypothalamus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    March 29, 2021
    Last Updated
    April 27, 2021
    Sponsor
    Wuhan Union Hospital, China
    search

    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

    We'll reach out to this number within 24 hrs