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Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

Primary Purpose

Gastrostomy, Head and Neck Neoplasms, Malignant Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Percutaneous radiologic gastrostomy
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrostomy focused on measuring percutaneous radiologic gastrostomy, Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto Nacional do Cancer - HC1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous radiologic gastrostomy.

Arm Description

Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of gastrostomy.
Duration of primary gastrostomy tube.
Technical success rate.
Gastrostomy tube insertion into gastric lumen.
Procedure duration time.
Time necessary to place the gastrostomy tube, from gastric distention to local dressing.
Pain intensity.
Pain will be measured according to pain score (1-10).
Additional procedures.
Procedures required after gastrostomy placement, like tube reinsertion or tube changes.

Full Information

First Posted
August 15, 2017
Last Updated
April 12, 2021
Sponsor
Instituto Nacional de Cancer, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03252509
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cancer, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrostomy, Head and Neck Neoplasms, Malignant Neoplasm
Keywords
percutaneous radiologic gastrostomy, Head and Neck Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous radiologic gastrostomy.
Arm Type
Experimental
Arm Description
Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous radiologic gastrostomy
Intervention Description
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 Outcome Measure Information:
Title
Complication rate.
Description
Rate of other complications like bleeding, infection, cutaneous fistulae.
Time Frame
Up to 24 weeks.
Secondary Outcome Measure Information:
Title
Duration of gastrostomy.
Description
Duration of primary gastrostomy tube.
Time Frame
Up to 24 weeks.
Title
Technical success rate.
Description
Gastrostomy tube insertion into gastric lumen.
Time Frame
Immediately.
Title
Procedure duration time.
Description
Time necessary to place the gastrostomy tube, from gastric distention to local dressing.
Time Frame
Immediately after the procedure.
Title
Pain intensity.
Description
Pain will be measured according to pain score (1-10).
Time Frame
Immediately after the procedure and during the total follow-up period - Up to 24 weeks.
Title
Additional procedures.
Description
Procedures required after gastrostomy placement, like tube reinsertion or tube changes.
Time Frame
Up to 24 weeks.
Other Pre-specified Outcome Measures:
Title
Gastrostomy outcomes after the follow-up period.
Description
Death for any reason using the gastrostomy tube, elective withdrawal after recovery of swallow function and persistence with gastrostomy tube.
Time Frame
Up to 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo R Gouveia
Organizational Affiliation
Instituto Nacional do Câncer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional do Cancer - HC1
City
Rio de Janeiro
ZIP/Postal Code
20.231-092
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

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