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Pituitary AdenomaGTR MRINCT07886242

Comparison of Extent of Resection of Pituitary Adenoma Via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope

A study testing Endoscopic surgery and Microscopic surgery in people with Pituitary Adenoma, run by Sir Ganga Ram Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial, titled "Comparison of Extent of Resection of Pituitary Adenoma via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope," was conducted in the Department of Neurosurgery, Sir Ganga Ram Hospital, Lahore, Pakistan, from 04 December 2022 to 03 December 2023. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Pituitary Adenoma
What is being tested?
Endoscopic surgery and Microscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
4 Dec 2022to 3 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The study includes patients diagnosed with pituitary adenoma who require
  • transnasal transsphenoidal surgery. Healthy volunteers without pituitary adenoma are not eligible for participation.

Who cannot join

  • The study includes patients diagnosed with pituitary adenoma who require transnasal transsphenoidal surgery.
  • Healthy volunteers without pituitary adenoma are not eligible for participation.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Department of Neurosurgery

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

This randomized controlled trial, titled "Comparison of Extent of Resection of Pituitary Adenoma via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope," was conducted in the Department of Neurosurgery, Sir Ganga Ram Hospital, Lahore, Pakistan, from 04 December 2022 to 03 December 2023. The objective was to compare the extent of pituitary adenoma resection using endoscopic and microscopic transnasal transsphenoidal surgery. A total of 38 patients aged 20-60 years of either gender were included. Patients with recurrent pituitary tumors or tumors with suprasellar or parasellar extension were excluded. Eligible patients were randomly allocated in a 1:1 ratio using random allocation software, and allocation concealment was maintained through sequentially numbered, sealed, opaque envelopes. Group A underwent endoscopic surgery, while Group B underwent microscopic surgery. Preoperative assessment included magnetic resonance imaging (MRI), hormonal investigations, perimetry, and routine investigations required for general anesthesia. Tumor volume was calculated using the specified geometrical formula based on tumor dimensions. Both surgical procedures were performed by the same surgical team to maintain consistency. Postoperative MRI was performed six weeks after surgery to assess residual tumor volume and extent of resection. Gross total resection (GTR) was defined as residual tumor volume below 10%, while subtotal resection was defined as residual tumor volume above 10%. The primary outcome was the extent of tumor resection assessed on postoperative MRI. Secondary outcomes included the percentage of tumor resected, tumor volume extracted, and duration of surgery. Data were analyzed using SPSS version 25.0. Quantitative variables were compared using the independent-samples t-test, while categorical variables were compared using the chi-square or Fisher's exact test, as appropriate. A p-value ≤0.05 was considered statistically significant. Ethical approval was obtained from the institutional ethics committee, and written informed consent was obtained from all participants.

Read the detailed description

Pituitary adenomas were sellar tumors that could cause visual disturbances, neurological manifestations, and hormonal abnormalities. The need for surgical treatment depended on tumor characteristics, functional status, and clinical presentation. Transnasal transsphenoidal surgery was an established approach for pituitary adenoma resection and had traditionally been performed using an operating microscope. With advances in endoscopic equipment and skull-base surgical techniques, endoscopic transnasal transsphenoidal surgery had increasingly been adopted as an alternative approach. Endoscopy provided panoramic visualization, magnification, improved illumination, and the ability to use angled lenses to inspect areas that were difficult to visualize using a microscope. These technical features facilitated access to the sellar and parasellar regions and improved visualization of tumor components extending beyond the direct microscopic line of sight. Both approaches aimed to achieve maximal safe tumor removal while preserving normal pituitary tissue and surrounding neurovascular structures. Previous comparative studies reported differences in the extent of tumor resection and operative duration between endoscopic and microscopic approaches; however, reported resection rates varied across studies, indicating the need for further comparative evaluation. Therefore, this randomized controlled trial was conducted to compare the extent of pituitary adenoma resection achieved through endoscopic and microscopic transnasal transsphenoidal surgery. The study was conducted in the Department of Neurosurgery, Sir Ganga Ram Hospital, Lahore, Pakistan, from 04 December 2022 to 03 December 2023. A total of 38 patients were included, with 19 patients allocated to each group. The sample size was calculated using a 95% confidence level and 80% power of the test, taking the expected percentage of resection as 88% in the endoscopic group and 47.8% in the microscopic group. Patients aged 20-60 years of either gender who underwent transnasal transsphenoidal surgery for pituitary adenoma were included. Patients with prolactinomas unresponsive to medical treatment or causing mass effects were also eligible. Patients with recurrent pituitary tumors and those with pituitary tumors having suprasellar or parasellar extension were excluded. After approval from the hospital ethics committee and obtaining written informed consent, eligible patients were enrolled from the neurosurgery outpatient department. Patients were randomly allocated in a 1:1 ratio using random allocation software. The randomization sequence was concealed through sequentially numbered, sealed, opaque envelopes prepared by the investigator. Group A underwent endoscopic transnasal transsphenoidal surgery, while Group B underwent microscopic transnasal transsphenoidal surgery. Demographic information, including age and gender, was recorded on a structured proforma. Preoperative assessment included magnetic resonance imaging (MRI) of the brain using plain and pituitary-protocol imaging to determine tumor dimensions and volume. Hormonal assessment included thyroid function tests, serum cortisol, growth hormone, and serum prolactin levels. Perimetry and routine investigations required for general anesthesia were also performed. Surgery in both groups was performed by the same surgical team, including the principal investigator, to maintain consistency in the operative procedure. In Group A, sphenoidotomy was performed to visualize the tuberculum and clival recess, followed by identification of the bilateral optic carotid recesses. The mucosa over the sellar floor was removed, and the medial optic carotid recesses and medial margins of the cavernous sinus were exposed. An adequate sellar bony window was created, followed by dural opening. Extracapsular debulking of the adenoma was performed circumferentially, with internal decompression carried out in a piecemeal fashion. When the tumor surrounded the anterior surface of the internal carotid artery, a direct approach to the lateral component of the cavernous sinus was used. An angled endoscope was used for tumor removal from the cavernous sinus, and blind curettage was not performed. Tumor severely adherent to the internal carotid artery or pituitary gland was not removed to avoid dangerous conditions. The sellar floor was repaired using an abdominal fat graft or fascia lata from the patient. In Group B, an incision was made in the mucosa of the right nostril, followed by creation of a submucosal plane along the septum up to the anterior wall of the sphenoid sinus. A Killian speculum was inserted, and the septum was subluxed and deviated. The microscope was brought into the operative field, and the sphenoid sinus was opened. The opening was enlarged to permit identification of the lateral portion of the sella, and the sellar position was confirmed under image guidance. The dura was visualized and incised, after which the tumor was identified and excised. Following tumor excision, the sellar floor was packed. The speculum was removed, the septum was returned to the midline, and the mucosa was repositioned. Nasal packing was removed on the fifth postoperative day, after which patients were discharged. Patients were called to the neurosurgery outpatient department six weeks after surgery, when MRI of the brain using plain and pituitary-protocol imaging was performed to calculate postoperative tumor volume and assess the extent of resection. All study information was recorded on the study proforma. Pituitary adenoma was defined as an adenoma of the pituitary gland detected on MRI in a patient planned for transsphenoidal pituitary adenoma surgery. Tumor volume was calculated in milliliters using the specified geometrical formula, ½ × length × width × height, based on tumor dimensions measured on preoperative and postoperative MRI. The extent of resection was assessed on postoperative MRI six weeks after surgery and classified as gross total resection or subtotal resection. Gross total resection (GTR) was defined as tumor excision with residual tumor volume less than 10%, while subtotal resection was defined as residual tumor volume greater than 10%. The primary outcome was the extent of pituitary adenoma resection assessed on postoperative MRI six weeks after surgery. Secondary outcomes included the percentage of tumor resected, tumor volume extracted, and duration of surgery. Data were collected by the principal investigator using a structured study proforma. Demographic characteristics, preoperative and postoperative MRI findings, tumor volume, extent of resection, percentage of tumor resected, and operative duration were documented. Data were entered and analyzed using Statistical Package for the Social Sciences (SPSS), version 25.0. Quantitative variables, including age, duration of symptoms, tumor volume, duration of surgery, and tumor volume extracted, were expressed as mean and standard deviation. Qualitative variables, including gender and extent of tumor resection, were presented as frequency and percentage. The independent-samples t-test was used to compare quantitative variables between the two groups, while the chi-square test or Fisher's exact test was used for categorical variables, as appropriate. Data were stratified according to age, gender, duration of symptoms, tumor volume, and duration of surgery. A p-value ≤0.05 was considered statistically significant. Ethical approval was obtained from the institutional ethics committee, and written informed consent was obtained from each participant before inclusion. Patient confidentiality was maintained, and study information was recorded on the study proforma. The study provided a comparative assessment of endoscopic and microscopic transnasal transsphenoidal surgery for pituitary adenoma, focusing on the extent of tumor resection, percentage of tumor removed, tumor volume extracted, and operative duration.

Being tested
Endoscopic surgery, Microscopic surgery
Keywords
transnasal transsphenoidal surgery., Pituitary Neoplasms, Transsphenoidal Surgery, Microsurgery, Gross Total Resection
Medical subject headings
Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic surgeryProcedure or surgery

    Endoscopic transnasal transsphenoidal surgery was performed for pituitary adenoma resection. The procedure involved sphenoidotomy, exposure of the sellar floor, creation of a sellar bony window, opening of the dura, and tumor removal by circumferential extracapsular debulking and piecemeal internal decompression. An angled endoscope was used when required to visualize the cavernous sinus. Tumor severely adherent to the internal carotid artery or pituitary gland was not removed. The sellar floor was repaired using an abdominal fat graft or fascia lata. Postoperative MRI was performed six weeks after surgery.

  • Microscopic surgeryProcedure or surgery

    Microscopic transnasal transsphenoidal surgery was performed for pituitary adenoma resection. The procedure involved a right nostril mucosal incision, creation of a submucosal plane along the nasal septum, insertion of a Killian speculum, and exposure of the sphenoid sinus using an operating microscope. The sphenoid opening was enlarged, and the sellar position was confirmed using image guidance. The dura was incised, and the tumor was identified and excised. The sellar floor was packed, and the speculum was removed. The septum was returned to the midline, and the nasal mucosa was repositioned. Postoperative MRI was performed six weeks after surgery.

Study groups in NCT07886242
Study groupRoleWhat they receive
Endoscopic surgeryExperimentalPatients allocated to Group A underwent endoscopic transnasal transsphenoidal surgery for pituitary adenoma. The procedure involved sphenoidotomy, exposure of the sellar floor, creation of a sellar bony window, opening of the dura, and tumor removal through circumferential extracapsular debulking and piecemeal internal decompression. An angled endoscope was used when required to visualize the cavernous sinus. Tumor severely adherent to the internal carotid artery or pituitary gland was not removed. The sellar floor was repaired using an abdominal fat graft or fascia lata. Postoperative MRI was performed six weeks after surgery to assess residual tumor volume and extent of resection.
Receives: Procedure: Endoscopic surgery
Microscopic surgeryActive comparatorPatients allocated to Group B underwent microscopic transnasal transsphenoidal surgery for pituitary adenoma. The procedure involved a right nostril mucosal incision, creation of a submucosal plane along the nasal septum, insertion of a Killian speculum, and exposure of the sphenoid sinus using an operating microscope. The sphenoid opening was enlarged, and the sellar position was confirmed using image guidance. The dura was incised, and the tumor was identified and excised. The sellar floor was packed, the speculum was removed, and the septum and nasal mucosa were repositioned. Postoperative MRI was performed six weeks after surgery to assess residual tumor volume and extent of resection.
Receives: Procedure: Microscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extent of Pituitary Adenoma Resection

    The extent of pituitary adenoma resection was assessed using postoperative magnetic resonance imaging (MRI) performed six weeks after surgery. Residual tumor volume was calculated from postoperative tumor dimensions. Gross total resection was defined as residual tumor volume below 10%, while subtotal resection was defined as residual tumor volume above 10%.

    Measured: Six weeks after surgery

Secondary outcomes (3)
  1. Percentage of Tumor Resected

    The percentage of pituitary adenoma resected was assessed by comparing preoperative and postoperative tumor volumes measured using MRI.

    Measured: Six weeks after surgery

  2. Tumor Volume Extracted

    Tumor volume extracted was determined by comparing preoperative tumor volume with residual tumor volume measured on postoperative MRI.

    Measured: Six weeks after surgery

  3. Duration of Surgery

    The duration of surgery was recorded for each patient and compared between the endoscopic and microscopic transnasal transsphenoidal surgery groups.

    Measured: Six weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start4 Dec 2022
  3. Primary completion3 Dec 2023
  4. Study completion3 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
his randomized controlled trial used a parallel-group design. A total of 38 patients with pituitary adenoma were randomly allocated in a 1:1 ratio into two groups. Group A underwent endoscopic transnasal transsphenoidal surgery, while Group B underwent microscopic transnasal transsphenoidal surgery. The extent of tumor resection was assessed using MRI six weeks after surgery. Tumor volume, percentage of tumor resected, and duration of surgery were also assessed.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07886242
Sponsor's protocol ID
No. 27-MS_Neurosurgery/IRB
Acronym
GTR MRI
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual data will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic surgery and Microscopic surgery in people with Pituitary Adenoma, run by Sir Ganga Ram Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Pituitary Adenoma Resection (time frame: Six weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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