Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05448690
• Collaborator: (none)
• Enrollment: 500
• Locations: 10
• Anticipated Duration (Months): 12
• Patients Per Site: 50
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Pituitary Adenoma	Procedure: Three different approaches

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Single approach Patients underwent transnasal approach or craniotomy approach	Procedure: Three different approaches; Please refer to Groups
Staged approach Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery	Procedure: Three different approaches; Please refer to Groups
Combined approach Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously	Procedure: Three different approaches; Please refer to Groups

Outcome Measures

Primary Outcome Measures

1. Extend of resection [Three months after surgery]

   how much tumor was resected

Secondary Outcome Measures

1. Risks [Three months after surgery]

   Proportion of Participants with hemorrage, infection or cranial nerve defect

2. Mortality [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 [Three months after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing People's Hospital	Chongqing	Chongqing	China
2	The first affliated hospital of Fujian Medical Hospital	Fuzhou	Fujian	China	350005
3	The First Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China
4	The First Affiliated Hospital of China Medical University	Shenyang	Jilin	China
5	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong	China
6	Huashan Hospital	Shanghai	Shanghai	China	20000
7	Shanghai General Hospital	Shanghai	Shanghai	China	20000
8	Shanghai Renji Hospital	Shanghai	Shanghai	China	20000
9	Changzhi People's Hospital	Changzhi	Shanxi	China
10	The first hospital of Shanxi Medical University	Taiyuan	Shanxi	China

Sponsors and Collaborators

• Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhaoyun Zhang, Prof, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT05448690
• Other Study ID Numbers: KY2022-060
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases

Study Results

No Results Posted as of Jul 12, 2022