Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

April 12, 2021 updated by: Instituto Nacional de Cancer, Brazil
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20.231-092
        • Instituto Nacional do Cancer - HC1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous radiologic gastrostomy.
Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
Procedure: Percutaneous radiologic gastrostomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate.
Time Frame: Up to 24 weeks.
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.
Time Frame: Up to 24 weeks.
Duration of primary gastrostomy tube.
Up to 24 weeks.
Technical success rate.
Time Frame: Immediately.
Gastrostomy tube insertion into gastric lumen.
Immediately.
Procedure duration time.
Time Frame: Immediately after the procedure.
Time necessary to place the gastrostomy tube, from gastric distention to local dressing.
Immediately after the procedure.
Pain intensity.
Time Frame: Immediately after the procedure and during the total follow-up period - Up to 24 weeks.
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.
Time Frame: Up to 24 weeks.
Procedures required after gastrostomy placement, like tube reinsertion or tube changes.
Up to 24 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrostomy outcomes after the follow-up period.
Time Frame: Up to 24 weeks.
Death for any reason using the gastrostomy tube, elective withdrawal after recovery of swallow function and persistence with gastrostomy tube.
Up to 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Investigators

  • Principal Investigator: Hugo R Gouveia, Instituto Nacional do Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA RI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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