What side effects are associated with this type of intervention?

Common treatments for pituitary tumors, particularly following endoscopic endonasal resection, can include nasal packing. The side effects of nasal packing often involve significant patient discomfort, requiring medication for pain management. Additionally, nasal packing can lead to increased hospitalization and healthcare costs. Other general side effects of pituitary tumor treatments may include headaches, nasal congestion, and potential complications from surgery such as infection or bleeding.

What prior FDA approvals exist?

The FDA has approved several treatments for pituitary tumors, primarily focusing on pharmacological agents and surgical interventions. Pharmacological treatments include dopamine agonists like cabergoline and bromocriptine for prolactinomas, and somatostatin analogs such as octreotide and lanreotide for growth hormone-secreting tumors. Additionally, pegvisomant, a growth hormone receptor antagonist, is used for acromegaly. Surgical resection, often performed via an endoscopic endonasal approach, is a common treatment for non-secreting and some secreting pituitary tumors. The use of nasal packing post-surgery, as studied in trials, aims to manage hemostasis and provide structural support, although its routine necessity remains debated.

What other types of research exist?

Promising alternatives to nasal packing for pituitary tumor patients include the use of hemostatic agents such as chitosan dressing, Kaolin-impregnated sponge, and fibrin sealant dressing. These agents have been developed to control bleeding effectively and may offer a less invasive and more comfortable option compared to traditional nasal packing.

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Nasal Packing After Pituitary Surgery

N/A

Recruiting

Led By Shaun Kilty, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

undergoing endoscopic endonasal transsphenoidal approach to pituitary resection for pituitary tumors of any pathology for the first time

18 years of age or older

Must not have

patients who do not have a working understanding of English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if using nasal packing after pituitary tumor surgery through the nose is necessary. The study focuses on patients who have this specific type of surgery. Nasal packing is supposed to help control bleeding and support healing, but it may cause discomfort and increase healthcare costs without clear benefits.

Who is the study for?

This trial is for adults over 18 who are having their first endoscopic surgery to remove pituitary tumors. Participants must understand English and not be allergic to Merocel nasal packing.

What is being tested?

The study aims to determine if using nasal packing after pituitary tumor surgery is necessary. Patients will either receive nasal packing or no packing at all, with the goal of assessing patient comfort and healthcare costs.

What are the potential side effects?

While the side effects are not detailed in this summary, it's common that nasal packing can cause discomfort requiring pain medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having my first surgery through the nose to remove a pituitary tumor.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a good understanding of English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anterior Skull Basal Nasal Inventory-12 (ASK-12)

Incidence of sinonasal adverse events

Secondary study objectives

Change in Analgesic and Antibiotic Usage

Change in EuroQual-5Dimension (EQ-5D)

Cost Analysis

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: No Nasal PackingExperimental Treatment1 Intervention

No nasal packing will be placed during or after the surgery.

Group II: Nasal PackingActive Control1 Intervention

Nasal packing will be placed at the end of surgery.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pituitary tumors include surgical resection, radiation therapy, and medical therapy. Surgical resection, often performed via an endoscopic endonasal approach, aims to physically remove the tumor, which can alleviate symptoms caused by mass effect and hormonal imbalances. Radiation therapy, including techniques like intensity-modulated radiation therapy (IMRT), targets and destroys tumor cells while sparing surrounding healthy tissue. Medical therapies, such as dopamine agonists or somatostatin analogs, work by inhibiting hormone secretion or shrinking the tumor. These treatments are crucial for managing pituitary tumors as they address both the physical presence of the tumor and its hormonal effects. In the context of nasal packing, which is used post-surgery to control bleeding and support healing, understanding these treatments helps in managing postoperative care and improving patient outcomes.