Application Research on Endoscopic Pseudocapsule-Based Resection for Pituitary Adenomas

NCT05466357 | Unknown

• 1 other identifier: AREPBRPA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pituitary adenomas are one of the most common primary central nervous system tumors and have an estimated prevalence of 17%. Management of pituitary adenomas involves a multidisciplinary approach that can incorporate surgical, medical, and/or radiation therapies. Over the last two decades, the endoscopic endonasal approach (EEA) has been extensively developed and refined for the resection of pituitary adenomas (PAs). In recent years, extracapsular resection (ER), which emphasized the importance of the pseudocapsule between the adenoma and surrounding normal gland tissue as a surgical plane, was adopted for more radical resection of the tumor. Therefore, dedicated high-resolution magnetic resonance imaging (MRI) protocols have been proposed to detect pituitary adenoma and accurately guide surgical removal. The evaluation of preoperative imaging for pseudocapsule is very important to the surgical method. Depending on different tumor sizes and pseudocapsule development, investigators adopted different resection strategies. To accomplish complete PA removal and minimize the impact on pituitary functions, intraoperative navigation was used to identify the tumor pseudocapsule, also the suspicious tissue was sent to the pathology department for histopathology intraoperatively. Long-term postoperative follow-up imaging and endocrine data were used to evaluate tumor prognosis. Standardized management and established biobank is critical for pituitary adenomas.

Conditions

Pituitary Adenoma

Keywords

pituitary adenomas; pseudocapsule; the endoscopic endonasal approach

Outcome Measures

Primary Outcomes (2)

• Tumor recurrence

  All patients undergo high-resolution magnetic resonance imaging (MRI) examination before operation, within 3 days, 3 months, 6 months, and twice per year after surgery. The degree of resection was calculated by measuring the residual tumor volume using MRI data. Comparing preoperative and postoperative tumor imaging changes, investigators will assess the helpfulness of preoperative imaging judgments for intraoperative tumor resection, and compare the efficacy of different surgical modalities.

  Change from baseline (before operation), within 3 days, 3 months, 6 months, 1 year and 2 years after surgery

• Endocrine change

  All patients undergo a baseline preoperative pituitary hormone examination. Hormonal status will be evaluated at 24 hours, 1 week, 1 month and 3 months after surgery and twice per year to evaluate anterior pituitary functions. Comparing preoperative and postoperative endocrine reduction, investigators will assess efficacy among different groups and different types of pituitary tumors.

  24 hours, 1 week, 1 month, 3 months, 6 months and 1 year after surgery

Secondary Outcomes (4)

• Including incidence of cerebrospinal fluid leakage

  Followed up for 2 weeks

• Incidence of intracranial infection

  Followed up for 2 weeks

• Incidence of visual and visual impairment

  Followed up for 2 weeks

• Incidence of subthalamic injury

  Followed up for 2 weeks

Study Arms (1)

Intracapsular excision of pituitary tumor

EXPERIMENTAL

Literature review was conducted to calculate the excision rate, postoperative recurrence rate and postoperative endocrine improvement of previous endoscopic intracapsular excision of pituitary tumor.

Procedure: Excision of pituitary tumor outside pseudocapsule

Interventions

Excision of pituitary tumor outside pseudocapsule PROCEDURE

Dedicated high-resolution magnetic resonance imaging (MRI) protocols have been proposed to detect pituitary adenoma and accurately guide surgical removal. To accomplish complete PA removal and minimize the impact on pituitary functions, intraoperative navigation was used to identify the tumor pseudocapsule. Depending on different tumor sizes and pseudocapsule development, investigators adopted different resection strategies. The suspicious tissue was sent to the pathology department for histopathology intraoperatively. Long-term postoperative follow-up imaging and endocrine data were used to evaluate tumor prognosis before and after operation. Standardized management and established biobank is critical for pituitary adenomas.

Intracapsular excision of pituitary tumor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to guidelines for treatment of pituitary tumors，Patients can be eligible for surgery.

You may not qualify if:

• Patients with other primary endocrine diseases.
• Patients with obviously suprasellar and parasellar extensions or with cavernous sinus invasion (grade 4 of knosp classification ).
• Patients with recent nasal trauma.
• Patients with nasal infection or/and sphenoid sinus inflammation.
• Patients with with abnormal coagulation.
• Patients with other serious diseases.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Subei People's Hospital of Jiangsu Province: collaborator
• The First People's Hospital of Changzhou: collaborator

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Related Publications (9)

• Cushing H. III. Partial Hypophysectomy for Acromegaly: With Remarks on the Function of the Hypophysis. Ann Surg. 1909 Dec;50(6):1002-17. doi: 10.1097/00000658-190912000-00003. No abstract available.

  PMID: 17862444 RESULT

• Jankowski R, Auque J, Simon C, Marchal JC, Hepner H, Wayoff M. Endoscopic pituitary tumor surgery. Laryngoscope. 1992 Feb;102(2):198-202. doi: 10.1288/00005537-199202000-00016. No abstract available.

  PMID: 1738293 RESULT

• Hardy J. Transsphenoidal hypophysectomy. 1971. J Neurosurg. 2007 Aug;107(2):458-71. doi: 10.3171/JNS-07/08/0458. No abstract available.

  PMID: 17695407 RESULT

• Costello RT. Subclinical Adenoma of the Pituitary Gland. Am J Pathol. 1936 Mar;12(2):205-216.1. No abstract available.

  PMID: 19970261 RESULT

• Oldfield EH, Vortmeyer AO. Development of a histological pseudocapsule and its use as a surgical capsule in the excision of pituitary tumors. J Neurosurg. 2006 Jan;104(1):7-19. doi: 10.3171/jns.2006.104.1.7.

  PMID: 16509142 RESULT

• Lee EJ, Ahn JY, Noh T, Kim SH, Kim TS, Kim SH. Tumor tissue identification in the pseudocapsule of pituitary adenoma: should the pseudocapsule be removed for total resection of pituitary adenoma? Neurosurgery. 2009 Mar;64(3 Suppl):ons62-9; discussion ons69-70. doi: 10.1227/01.NEU.0000330406.73157.49.

  PMID: 19240574 RESULT

• Taylor DG, Jane JA, Oldfield EH. Resection of pituitary macroadenomas via the pseudocapsule along the posterior tumor margin: a cohort study and technical note. J Neurosurg. 2018 Feb;128(2):422-428. doi: 10.3171/2017.7.JNS171658. Epub 2017 Aug 18.

  PMID: 28820308 RESULT

• Nagata Y, Takeuchi K, Yamamoto T, Ishikawa T, Kawabata T, Shimoyama Y, Inoshita N, Wakabayashi T. Peel-off resection of the pituitary gland for functional pituitary adenomas: pathological significance and impact on pituitary function. Pituitary. 2019 Oct;22(5):507-513. doi: 10.1007/s11102-019-00980-w.

  PMID: 31377966 RESULT

• Li QX, Wang WH, Wang XX. Various Strategies of Transsphenoidal Pseudocapsule-Based Extracapsular Resection in Noninvasive Functional Pituitary Adenomas and their Effectiveness and Safety. Neurol India. 2019 Nov-Dec;67(6):1448-1455. doi: 10.4103/0028-3886.273628.

  PMID: 31857533 RESULT

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• xiao mingbing, MD

  Affiliadted hospital of nantong university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shi wei, MD

CONTACT

0086-13585225222; sw740104@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: July 20, 2022
• Study Start: December 28, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 6, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)