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Completed

NCT Number: NCT03252509

Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional do Cancer - HC1

Rio de Janeiro, 20.231-092, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous radiologic gastrostomy

Procedure

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.

Primary outcomes

  1. Complication rate.

    Time frame: Up to 24 weeks.

    Rate of other complications like bleeding, infection, cutaneous fistulae.

Secondary outcomes

  1. Duration of gastrostomy.

    Time frame: Up to 24 weeks.

    Duration of primary gastrostomy tube.

  2. Technical success rate.

    Time frame: Immediately.

    Gastrostomy tube insertion into gastric lumen.

  3. Procedure duration time.

    Time frame: Immediately after the procedure.

    Time necessary to place the gastrostomy tube, from gastric distention to local dressing.

  4. 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).

  5. Additional procedures.

    Time frame: Up to 24 weeks.

    Procedures required after gastrostomy placement, like tube reinsertion or tube changes.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancer, Brazil

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2017
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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