Clinical trial NCT03252509: Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
Official title: Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Head and Neck Neoplasms
Malignant Neoplasm
Keywords: percutaneous radiologic gastrostomy
Head and Neck Neoplasms
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-08-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study intends to evaluate the security and success rate of large bore percutaneous radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.

Detailed description: Percutaneous gastrostomy is a procedure that intends to provide prolonged alimentary access to patients with normal gastrointestinal tract, which are unable to eat or are facing troubles with deglutition.

Nowadays it is considered as the first line procedure to prolonged enteral access on this patients.

The indications to perform a percutaneous gastrostomy in a cancer center are usually related to head and neck, central nervous system and esophagus tumors. In our institution around 80% of the percutaneous gastrostomy are performed in patients with head an neck tumors.

Although percutaneous gastrostomy is considered a safe procedure, there are some complications related, specially in oncologic patients. Those complications are reported in about 40% of the cases.

Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to hospitalization costs. However, some studies have shown that is safe and viable to perform percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in patients with head a neck tumors.

As both techniques (endoscopic and radiologic) present similar results, patients treated in our institution that require a percutaneous gastrostomy are referred to endoscopic and interventional radiology departments.

Some of these patients are selected to undergo an outpatient procedure, based on social and clinical criteria.

The majority of the available data shows that both the endoscopic and the radiologic techniques present similar results in terms of security and rate of precocious and late complications, and that both are superior than the surgical technique, considering they are least invasive and related with lower rates of complication and costs.

In the present, the traction (Gauderer-Ponsky) technique is the most widely used in our institution for the endoscopic procedure.

In the interventional radiology department the percutaneous gastrostomy is performed using the introduction (Russel) technique, in which a guidewire is positioned after the stomach needle puncture, made under ultrasound or fluoroscopic guidance. After that, the tract is progressively dilated to allow the introduction of the gastrostomy balloon catheter, through the abdominal wall, using a peel-away sheath.

This same technique can be performed for the endoscopic gastrostomy, using the same gastrostomy kit, but under endoscopic guidance.

Some authors suggest that the introduction technique, although more challenging, is associated with less stoma infections, because is the only one that is not associated with oral catheterization.

For the patients with head an neck tumors, there is also a reduced risk of metastases implants on the puncture site.

Besides those considerations, the data available is still not consensual.

Eligibility criteria: Inclusion Criteria:

* Surgical risk ASA I-III, Karnofsky Performance Status \>70, acceptance and comprehension of the orientations and after-care, adequate social a familiar support, easy access to the hospital.

Exclusion Criteria:

* patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol.

Primary outcomes:
measure: Complication rate.
timeFrame: Up to 24 weeks.
Secondary outcomes:
measure: Duration of gastrostomy.
timeFrame: Up to 24 weeks.
measure: Technical success rate.
timeFrame: Immediately.
measure: Procedure duration time.
timeFrame: Immediately after the procedure.
measure: Pain intensity.
timeFrame: Immediately after the procedure and during the total follow-up period - Up to 24 weeks.
measure: Additional procedures.
timeFrame: Up to 24 weeks.
Other outcomes:
measure: Gastrostomy outcomes after the follow-up period.
timeFrame: Up to 24 weeks.
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer - HC1
Study officials:
affiliation: Instituto Nacional do Câncer
name: Hugo R Gouveia
role: PRINCIPAL_INVESTIGATOR
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