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Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

I

Instituto Nacional de Cancer, Brazil

Status

Completed

Conditions

Malignant Neoplasm
Gastrostomy
Head and Neck Neoplasms

Treatments

Procedure: Percutaneous radiologic gastrostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03252509
INCA RI

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

39 participants in 1 patient group

Percutaneous radiologic gastrostomy.
Experimental group
Description:
Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
Treatment:
Procedure: Percutaneous radiologic gastrostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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