Investigation of pituitary gland function after Endoscopic Transsphenoidal Surgery (ETSS) in pituitary adenoma and corresponding factors in recovery of pituitary function
Evaluation of pituitary gland function after endoscopic transsphenoidal surgery (ETSS) in pituitary adenomas and the factors affecting recovery of gland function.
Assessment of the association between the occurrence of pituitary dysfunction after ETSS in pituitary adenomas and the gland’s recovery status in relation to tumor pathology, tumor size and invasion, preop pituitary dysfunction, preop hormonal medication usage, and number of surgeries and re-op.
Design
A quasi-experimental study by evaluation before and following patients after ETSS, 3, 6 and 12 months post-op by assessment of hormonal function and MRI of pituitary gland, alongside histopathologic and clinical examination
Settings and conduct
Patients with pituitary adenomas who present to Shariati Hospital and the Dr. Guive Sharifi Pituitary Clinic for surgical treatment will be enrolled in the study after receiving a full explanation of the study conditions and providing informed consent.
Preoperative data collected from patients include MRI findings, clinical history focusing on symptoms specific to pituitary tumors, and pituitary hormonal tests alongside relevant paraclinical findings.
Patients then undergo surgery (intervention), during which any complication and potential lesion is recorded. The follow-up visits take place 3, 6 and 12 months after surgery, at which tumor histopathology, MRI, updated laboratory tests, and reassessment of clinical symptoms are documented alongside any possible complications.
Participants/Inclusion and exclusion criteria
Candidates of ETSS due to Pituitary Adneoma are enrolled.
Any pathology other than PitNET and Pituitary Adenoma are outrolled.
Intervention groups
Candidates of ETSS due to Pituitary Adenoma
Main outcome variables
hypopituitarism (defined as deficiency in at least one pituitary axis)
recovery (defined as restoration of function in at least one previously deficient axis).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260430069219N1
Registration date:2026-08-08, 1405/05/17
Registration timing:registered_while_recruiting
Last update:2026-08-08, 1405/05/17
Update count:0
Registration date
2026-08-08, 1405/05/17
Registrant information
Name
Yassan Farmani Djamea
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 0309
Email address
y-farmanijame@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-13, 1403/04/23
Expected recruitment end date
2026-08-20, 1405/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of pituitary gland function after Endoscopic Transsphenoidal Surgery (ETSS) in pituitary adenoma and corresponding factors in recovery of pituitary function
Public title
Pituitary function after ETSS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pituitary Adenoma
ETSS Surgery
Exclusion criteria:
Pathology other than Pituitary Adenoma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Patients who are candidates for ETSS surgery and present to the clinic are enrolled in the study after providing informed consent. Their pituitary function and anatomy are evaluated through laboratory tests and MRI.These assessments are then repeated at 3, 6, and 12 months after surgery, in accordance with international guidelines for postoperative pituitary follow-up. Alongside these, the patient’s overall condition, tumor pathology, medication use, and any potential intraoperative complications are considered together, and their relationships are analyzed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Poorsina ave., Enghelab Sq.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-09-30, 1403/07/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.273
Health conditions studied
1
Description of health condition studied
Pituitary gland function after ETSS in Pituitary Adenoma
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Pituitary Adenoma
ICD-10 code
D35.2
ICD-10 code description
Benign neoplasm of pituitary gland
3
Description of health condition studied
Post-ETSS hypopituitarism
ICD-10 code
E89.3
ICD-10 code description
Postprocedural hypopituitarism
Primary outcomes
1
Description
Incidence of hypopituitarism
Timepoint
3, 6, and 12 months after ETSS surgery
Method of measurement
Pituitary hormonal examination
2
Description
Rate of recovery from hypopituitarism
Timepoint
3, 6, and 12 months after ETSS surgery
Method of measurement
Pituitary hormonal examination
Secondary outcomes
empty
Intervention groups
1
Description
ETSS surgery for Pituitary Adenoma
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Milad Shafizadeh
Street address
Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Guive Sharifi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dean.medicalschool@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Neuroscience Institute
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yassan Farmani Djamea
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Poorsina ave., Enghelab Sq.
City
Tehran
Province
Tehran
Postal code
1463693835
Phone
+98 21 2255 0309
Email
yasanjame@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Milad Shafizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 2612 2430
Email
milad_shafizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Yassan Farmani Djamea
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Poorsina ave., Enghelab Sq.
City
Tehran
Province
Tehran
Postal code
1463693835
Phone
+98 21 2255 0309
Email
yasanjame@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Methodology of the study and its results
When the data will become available and for how long
After publication of article
To whom data/document is available
Researchers active in universities and academic centers
Under which criteria data/document could be used
Access to raw and pre-analyzation data other than those published, will not be possible