Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04309825 |
| Other study ID # |
2000027348 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
April 1, 2025 |
Study information
| Verified date |
December 2020 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Upper GI endoscopies are commonly done by inserting the endoscope through the patient's
mouth. When a patient has a gastrostomy feeding tube, the endoscope can be inserted through
the stomach port opening. The aim is to prove this modification would lead to various health
benefits, including need for lighter anesthesia, rapid recovery time and fewer anesthesia
related adverse reactions.
Description:
Pediatric esophagogastroduodenoscopies (EGD) are commonly used for diagnosis and treatment of
various GI conditions. Appropriate sedation or anesthesia and analgesia is critical for
enhancing the effectiveness and feasibility of EGD. General anesthesia or deep sedation are
commonly used for this procedure. Midazolam is the most common intravenous sedative in use,
often in combination with ketamine, propofol, meperidine or fentanyl.
Despite technical advances in patient monitoring and the safety of anesthesia and sedation
drugs, procedural anesthesia or sedation adverse events may occur. Desaturation during the
procedure is the most common adverse event, followed by vomiting, excessive secretion and
unexpected apnea. Children with aero-digestive pathologies and feeding disorders often carry
significant underlying co-morbidities, increasing their anesthesia risk. Previous studies
have shown that caution must be exercised in children with potential airway problems or
uncorrected cardiopulmonary anomalies such as laryngomalacia, chromosomal abnormalities,
tetralogy of fallot and bronchopulmonary dysplasia. In addition, this population is often at
increased risk for concurrent respiratory conditions, which may increase the risk for
laryngospasm during the procedure.
As the endoscope is inserted transorally, it may also be an important trigger for
laryngospasm. Alternatives to oral insertion of the endoscope have been described and shown
to be more beneficial than the oral route in some patients. For example, previous studies
have shown that transnasal endoscopies are known to be less of a burden to patients, and have
benefits including fewer effects on respiratory and cardiovascular status and reduced
recovery time after procedure.
Alternatively, insertion of the endoscope through the gastrocutaneous tract is possible among
patients with a percutaneous gastrostomy feeding tube. This technique has been well described
in the adult population for observation, diagnosis and treatment of various digestive
diseases. As children with aero-digestive and feeding disorders often have a percutaneous
gastrostomy feeding tube, and are at increased risk for anesthesia adverse events,
transgastrostomal endoscopies me be beneficial in this patient population. To date, this
method has not been reported and examined in children undergoing EGDs.
The aims of this study:
1. Examine the feasibility of transgastrostomal EGDs in children Assess the ability to
explore the upper GI tract from proximal esophagus to the second part of the duodenum
and obtain adequate tissue biopsies.
2. Assess the need for anesthesia and sedation In the adult population transgastrostomal
endoscopies are done with no anesthesia or sedation. Previous studies on adult
population have shown that even with lack of sedation, this procedure was not associated
with any decrease of oxygen saturation nor a significant difference in fluctuations of
blood pressures and heart rate in comparison to oral EGDs. As for children, a "lighter"
anesthesia with inhalation with a face mask or sedation with intranasal application of
dexmedetomidine hydrochloride may provide adequate anesthesia or sedation for this
procedure. However, the decision regarding the type of anesthesia used during endoscopy
remains per anesthesiologist discretion and is not part of this study.
3. Examine the benefits of this procedure in comparison to oral EGD Specifically, will
examine the rate of procedural sedation or anesthesia adverse events and patients'
recovery time.
4. Research Plan:
Study will take place at the children's operating room of Yale New Haven Hospital.
Enrollment to the study will take place on the day of the endoscopy during the pre-procedural
assessment. Eligible patients will be offered to have a transgastrostomal endoscopy instead
of a transoral one.
Similar to a transoral EGD, on the patient's arrival to the operating room (OR) the
anesthesia team will obtain vital signs (blood pressure, heart rate, respiratory rate and
oxygen saturation). Those would be monitored continuously during the procedure.
Once the preprocedural assessment is completed, the anesthesiologist will determine the type
of anesthesia: intravenous drugs, gas inhalation or intranasal dexmedetomidine hydrochloride
at a standard dosage of 2 mcg/kg. As "lighter" anesthesia may be used in this study (compared
to transoral EGDs), the depth of anesthesia will be continuously monitored. The patients will
be connected to a bispectral index (BIS) monitor, which identifies changes in
electrophysiologic brain activity during general anesthesia. The BIS monitor, derived from
electroencephalogram (EEG) data, has been shown to be a useful cerebral monitor of anesthesia
depth.
Once the patient is laid in the supine position, the gastrostomy tube is removed. After
applying a lubricant around the endoscope, it is inserted through the fistural tract and
advanced into the gastric lumen. At this point a standard endoscopy will be conducted (with
no significant changes compared to a transoral EGD). The endoscope is directed to the oral
side and advanced to the esophagogastric junction. The endoscope is retrogradely inserted
through the esophagus, and proximal and distal esophageal biopsies are obtained. The
endoscope is then withdrawn to the stomach and directed to the anal side. The endoscope is
inserted up to the second part of the duodenum from the stoma. Duodenal biopsies are obtained
from the 2nd duodenal part and the duodenal bulb. The endoscope is pulled back to the stomach
and turned back to look around the stoma. Gastric biopsies are obtained from the body of the
stomach and the pre-pyloric region. After observation of the upper gastrointestinal tract,
air is suctioned and the endoscope is withdrawn from the stoma. The gastrostomy tube is
placed.
Procedure length is estimated at 15 minutes.
The main differences between a standard transoral endoscopy and a trandgastrotsotmal one are:
1. Insertion of the endoscope through the G-tube port and not the mouth.
2. The need to remove the existing G-tube and replace it once the endoscopy is done
3. Potential use of "lighter" sedation. In this study the depth of anesthesia will be
monitored with a BIS monitor. This monitor is not used during a standard EGD.
The procedure's efficacy, length and adverse reaction will be compared to the standard
transoral endoscopy.
