Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

Conditions
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Gastrostomy, Head and Neck Neoplasms, Malignant Neoplasm

Intervention / Treatment
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* Procedure: Percutaneous radiologic gastrostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous radiologic gastrostomy.<br>Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment. | Procedure: Percutaneous radiologic gastrostomy<br>* Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate. | Rate of other complications like bleeding, infection, cutaneous fistulae. | Up to 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of gastrostomy. | Duration of primary gastrostomy tube. | Up to 24 weeks. | 
| Technical success rate. | Gastrostomy tube insertion into gastric lumen. | Immediately. | 
| Procedure duration time. | Time necessary to place the gastrostomy tube, from gastric distention to local dressing. | Immediately after the procedure. | 
| Pain intensity. | Pain will be measured according to pain score (1-10). | Immediately after the procedure and during the total follow-up period - Up to 24 weeks. | 
| Additional procedures. | Procedures required after gastrostomy placement, like tube reinsertion or tube changes. | Up to 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous radiologic gastrostomy, Head and Neck Neoplasms