NCT04863456

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

March 29, 2021

Last Update Submit

April 27, 2021

Conditions

Pituitary Adenoma

Keywords

pituitary adenomatreatment strategyHypothalamus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change of Visual Acuity statue

    baseline (before the first surgery), 2 years after the first surgery

  • Change of Visual Field statue

    baseline (before the first surgery), 2 years after the first surgery

  • Change of Hormone Replacement Therapy

    baseline (before the first surgery), 2 years after the first surgery

  • Extent of resection

    baseline (before the first surgery), 2 years after the first surgery

Study Arms (2)

HIPA group of Puget grade 1

EXPERIMENTAL

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

Procedure: Total resectionProcedure: Staged resectionProcedure: Subtotal resection followed by stereotactic radiation therapy

HIPA group of Puget grade 2

EXPERIMENTAL

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

Procedure: Total resectionProcedure: Staged resectionProcedure: Subtotal resection followed by stereotactic radiation therapy

Interventions

Total resectionPROCEDURE

Total resection of HIPA in a single surgery

HIPA group of Puget grade 1HIPA group of Puget grade 2
Staged resectionPROCEDURE

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

HIPA group of Puget grade 1HIPA group of Puget grade 2
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

HIPA group of Puget grade 1HIPA group of Puget grade 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Tao Huang, PhD, MD

    Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Tao Huang, PhD, MD

CONTACT

027-85350819neuroht@hust.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 28, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

April 28, 2021

Record last verified: 2021-04