Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

October 13, 2022 updated by: Zhaoyun Zhang, Huashan Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing People's Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The first affliated hospital of Fujian Medical Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • The First Affiliated Hospital of Guizhou Medical University
        • Contact:
          • Liangzhao Chu
          • Phone Number: 0851-86855119
          • Email: XXX@xxx.com
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • General Hospital of eastern theater command
        • Contact:
          • Chiyuan Ma
          • Phone Number: 025-80860114
          • Email: XXX@xxx.com
    • Jilin
      • Shenyang, Jilin, China
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
          • Wei Gao
          • Phone Number: 024-83283333
          • Email: XXX@xxx.com
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Hui Ma
          • Phone Number: 0951-4091488
          • Email: XXX@xx.cn
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • The First Affiliated Hospital Of Shandong First Medical University
        • Contact:
          • Meng Li
          • Phone Number: 0531-89268265
          • Email: xxx@xxx.com
    • Shanghai
      • Shanghai, Shanghai, China, 20000
      • Shanghai, Shanghai, China, 20000
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai, China, 20000
        • Recruiting
        • Shanghai Renji Hospital
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China
        • Recruiting
        • Changzhi People's Hospital
        • Contact:
          • Wenlong Tang
          • Phone Number: 0355-2024990
          • Email: XXX@xxx.com
      • Taiyuan, Shanxi, China
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
          • Wenxiong Wang
          • Phone Number: 0351-4639114
          • Email: XXX@xxx.com
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The first affliated hospital of Kunming Medical University
        • Contact:
          • Xingli Deng
          • Phone Number: 0871-65324888
          • Email: XXX@xx.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Time Frame: One month after surgery
how much tumor was resected
One month after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

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 17, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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