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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pituitary Adenoma
• Intervention / Treatment: Procedure: Total resection; Procedure: Staged resection; Procedure: Subtotal resection followed by stereotactic radiation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Huang, PhD, MD; Phone Number: 027-85350819; Email: neuroht@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPA group of Puget grade 1; the tumor abuting or displacing the hypothalamus in the preoperative MR images	Procedure: Total resection; Total resection of HIPA in a single surgery; Procedure: Staged resection; HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date; 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
Experimental: HIPA group of Puget grade 2; hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images	Procedure: Total resection; Total resection of HIPA in a single surgery; Procedure: Staged resection; HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Study Director: Tao Huang, PhD, MD, Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pituitary adenoma; Hypothalamus; treatment strategy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: [2021]IEC-J(227)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No