Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.

A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.

The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.

In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.

Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.

Study Overview

• Status: Completed
• Conditions: Pituitary Adenoma; Surgery
• Intervention / Treatment: Procedure: Two different approaches; Procedure: Non-combined approach

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Chongqing People's Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The first affliated hospital of Fujian Medical Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • The First Affiliated Hospital of Guizhou Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • General Hospital of Eastern Theater Command
  • Jilin
    • Shenyang, Jilin, China
      • The First Affiliated Hospital of China Medical University
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China
      • The First Affiliated Hospital of Shandong First Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 20000
      • Shanghai Renji Hospital
    • Shanghai, Shanghai, China, 20000
      • Huashan Hospital
    • Shanghai, Shanghai, China, 20000
      • Shanghai General Hospital
  • Shanxi
    • Changzhi, Shanxi, China
      • Changzhi People's Hospital
    • Taiyuan, Shanxi, China
      • The First Hospital of Shanxi Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • The first affliated hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients with a preoperative diagnosis of complex giant pituitary adenoma.

Description

Inclusion Criteria:

• Giant pituitary adenoma (> 4cm in diameter)

Exclusion Criteria:

• most of the tumor were in the sellae, sphenoidal sinus or clivus.
• patients with craniopharyngioma or meningioma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-combined approach (Single or Staged); Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery	Procedure: Non-combined approach; Either transnasal, transcranial or a staged approach
Experimental: Combined approach; Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously	Procedure: Two different approaches; Please refer to Groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extend of resection	how much tumor was resected	One month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risks	Proportion of Participants with hemorrage, infection or cranial nerve defect	One month after surgery
Relapse or Mortality	Death from any cause	From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery
Karnofsky performance score	Ranged from 0 to 100, the higher scores mean a better outcome	Three months after surgery

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Nervous System Neoplasms; Central Nervous System Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: KY2022-060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No