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

NCT ID: NCT04863456

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-31

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.

Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HIPA group of Puget grade 1

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

Group Type EXPERIMENTAL

Total resection

Intervention Type PROCEDURE

Total resection of HIPA in a single surgery

Staged resection

Intervention Type PROCEDURE

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

Subtotal resection followed by stereotactic radiation therapy

Intervention Type PROCEDURE

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

HIPA group of Puget grade 2

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

Group Type EXPERIMENTAL

Total resection

Intervention Type PROCEDURE

Total resection of HIPA in a single surgery

Staged resection

Intervention Type PROCEDURE

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

Subtotal resection followed by stereotactic radiation therapy

Intervention Type PROCEDURE

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

Interventions

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Total resection

Total resection of HIPA in a single surgery

Intervention Type PROCEDURE

Staged resection

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

Intervention Type PROCEDURE

Subtotal resection followed by stereotactic radiation therapy

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Huang, PhD, MD

Role: STUDY_DIRECTOR

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

Central Contacts

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Tao Huang, PhD, MD

Role: CONTACT

027-85350819

Other Identifiers

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[2021]IEC-J(227)

Identifier Type: -

Identifier Source: org_study_id

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