EsophagogastroduodenoscopiesNCT04309825
Transgastrostomal Endoscopies
A study testing transgastrostomal endoscopy in people with Esophagogastroduodenoscopies, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Esophagogastroduodenoscopies
- What is being tested?
- transgastrostomal endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with a percutaneous gastrostomy feeding tube, who are about to have a diagnostic esophagogastroduodenoscopy.
Who cannot join
- age>18 years,
- G-tube size <12Fr.
- Patients with immature gastrocutaneous fistula (< 4 weeks after gastrostomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transgastrostomal Esophagogastroduodenoscopies in Children
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- 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:
- Insertion of the endoscope through the G-tube port and not the mouth.
- The need to remove the existing G-tube and replace it once the endoscopy is done
- 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.
- Conditions
- Esophagogastroduodenoscopies
- Being tested
- transgastrostomal endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transgastrostomal endoscopyProcedure or surgery
Placement the endoscope through the g-tube port and not through the mouth of a patient undergoing an upper gi endoscopy
| Study group | Role | What they receive |
|---|---|---|
| G-tube endoscopies patients | Experimental | patients who will undergo an endoscopy through g-tube port Receives: Procedure: transgastrostomal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain adequate biopsies
Conduct a full endoscopy via g-tube port. Advance the scope to all standard locations including proximal esophagus, distal esophagus, stomach, duodenal bulb and the second part of the duodenum. Obtain at least 2 specimens from each location.
Measured: 15 minutes
Secondary outcomes (1)
anesthesia related adverse reactions
Assess the rate of anesthesia related adverse reactions. Specifically, record the number of oxygen desaturations during the endoscopy (vital signs are continuously recorded during the exam). After the procedure the anesthesia team will summarize any anesthesia adverse reactions that have occurred during the exam.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Why it stopped: no IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopiesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To examine the efficacy of transgastrostomal endoscopies among a single group of patients with a gastrostomy feeding tube
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309825
- Sponsor's protocol ID
- 2000027348
- Status last verified
- Dec 2020
- First submitted
- 12 Mar 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedt M, Welsch S. An update on pediatric endoscopy. Eur J Med Res. 2013 Jul 25;18(1):24. doi: 10.1186/2047-783X-18-24.
PubMed 23885793van Beek EJ, Leroy PL. Safe and effective procedural sedation for gastrointestinal endoscopy in children. J Pediatr Gastroenterol Nutr. 2012 Feb;54(2):171-85. doi: 10.1097/MPG.0b013e31823a2985.
PubMed 21975965Campo R, Montserrat A, Brullet E. Transnasal gastroscopy compared to conventional gastroscopy: a randomized study of feasibility, safety, and tolerance. Endoscopy. 1998 Jun;30(5):448-52. doi: 10.1055/s-2007-1001306.
PubMed 9693891Dumortier J, Ponchon T, Scoazec JY, Moulinier B, Zarka F, Paliard P, Lambert R. Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc. 1999 Mar;49(3 Pt 1):285-91. doi: 10.1016/s0016-5107(99)70002-7.
PubMed 10049409Mori A, Ohashi N, Maruyama T, Tatebe H, Sakai K, Shibuya T, Inoue H, Takegoshi S, Okuno M. Transnasal endoscopic retrograde chalangiopancreatography using an ultrathin endoscope: a prospective comparison with a routine oral procedure. World J Gastroenterol. 2008 Mar 14;14(10):1514-20. doi: 10.3748/wjg.14.1514.
PubMed 18330940Adler DG, Gostout CJ, Baron TH. Percutaneous transgastric placement of jejunal feeding tubes with an ultrathin endoscope. Gastrointest Endosc. 2002 Jan;55(1):106-10. doi: 10.1067/mge.2002.119257.
PubMed 11756929
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transgastrostomal Esophagogastroduodenoscopies in Children
- ClinicalTrials.gov ID
- NCT04309825
- Acronym / sponsor ID
- 2000027348
- Conditions
- Esophagogastroduodenoscopies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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.
- 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:
- Insertion of the endoscope through the G-tube port and not the mouth.
- The need to remove the existing G-tube and replace it once the endoscopy is done
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To examine the efficacy of transgastrostomal endoscopies among a single group of patients with a gastrostomy feeding tube
| Arm | Type | Receives |
|---|---|---|
| G-tube endoscopies patients | Experimental | Procedure: transgastrostomal endoscopypatients who will undergo an endoscopy through g-tube port |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with a percutaneous gastrostomy feeding tube, who are about to have a diagnostic esophagogastroduodenoscopy.
Key exclusion criteria (3 listed)
- age>18 years,
- G-tube size <12Fr.
- Patients with immature gastrocutaneous fistula (< 4 weeks after gastrostomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transgastrostomal endoscopyPlacement the endoscope through the g-tube port and not through the mouth of a patient undergoing an upper gi endoscopy | Procedure or surgery | G-tube endoscopies patients |
Primary outcome
Obtain adequate biopsies
Time frame: 15 minutes
Conduct a full endoscopy via g-tube port. Advance the scope to all standard locations including proximal esophagus, distal esophagus, stomach, duodenal bulb and the second part of the duodenum. Obtain at least 2 specimens from each location.
1 secondary outcome
anesthesia related adverse reactions
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Background: PubMed 23885793Friedt M, Welsch S. An update on pediatric endoscopy. Eur J Med Res. 2013 Jul 25;18(1):24. doi: 10.1186/2047-783X-18-24.
- Background: PubMed 21975965van Beek EJ, Leroy PL. Safe and effective procedural sedation for gastrointestinal endoscopy in children. J Pediatr Gastroenterol Nutr. 2012 Feb;54(2):171-85. doi: 10.1097/MPG.0b013e31823a2985.
- Background: PubMed 9693891Campo R, Montserrat A, Brullet E. Transnasal gastroscopy compared to conventional gastroscopy: a randomized study of feasibility, safety, and tolerance. Endoscopy. 1998 Jun;30(5):448-52. doi: 10.1055/s-2007-1001306.
- Background: PubMed 10049409Dumortier J, Ponchon T, Scoazec JY, Moulinier B, Zarka F, Paliard P, Lambert R. Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc. 1999 Mar;49(3 Pt 1):285-91. doi: 10.1016/s0016-5107(99)70002-7.
- Background: PubMed 18330940Mori A, Ohashi N, Maruyama T, Tatebe H, Sakai K, Shibuya T, Inoue H, Takegoshi S, Okuno M. Transnasal endoscopic retrograde chalangiopancreatography using an ultrathin endoscope: a prospective comparison with a routine oral procedure. World J Gastroenterol. 2008 Mar 14;14(10):1514-20. doi: 10.3748/wjg.14.1514.
- Background: PubMed 11756929Adler DG, Gostout CJ, Baron TH. Percutaneous transgastric placement of jejunal feeding tubes with an ultrathin endoscope. Gastrointest Endosc. 2002 Jan;55(1):106-10. doi: 10.1067/mge.2002.119257.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transgastrostomal endoscopy in people with Esophagogastroduodenoscopies, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain adequate biopsies (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309825, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.