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OpenTrials
Completed

NCT Number: NCT05448690

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.

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Key information

Age range

6 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing People's Hospital, Chongqing, Chongqing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two different approaches

Procedure

Please refer to Groups

Non-combined approach

Procedure

Either transnasal, transcranial or a staged approach

Primary outcomes

  1. Extend of resection

    Time frame: One month after surgery

    how much tumor was resected

Secondary outcomes

  1. Risks

    Time frame: One month after surgery

    Proportion of Participants with hemorrage, infection or cranial nerve defect

  2. 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

  3. Karnofsky performance score

    Time frame: Three months after surgery

    Ranged from 0 to 100, the higher scores mean a better outcome

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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