Acute Upper Gastrointestinal BleedingPhase 4NCT04771481
Metoclopramide for Acute Upper GI Bleeding
A Phase 4 study testing Metoclopramide and Normal Saline 10 mL Injection in people with Acute Upper Gastrointestinal Bleeding and Effect of Drug, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
Trial summary
The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Bleeding, Effect of Drug
- What is being tested?
- Metoclopramide and Normal Saline 10 mL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesThailand
- Study dates
- 10 Apr 2021to 8 Oct 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Active upper GI bleeding ( defined as fresh or bright red hematemesis within 24hr. or presented of blood via NG aspiration )
- Underwent upper GI endoscopy within 12hr
- Informed consent obtained
Who cannot join
- Known allergy of metoclopramide
- History of gastric or duodenal surgery
- Known case esophageal, gastric or duodenal cancer
- Diagnosed with advanced HIV infection (defined as CD4 cell count <200 cells/mm3 or WHO clinical stage 3 or 4)
- Pregnancy or lactating
- NG lavage was done with solution > 50 ml.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
King chulalongkorn memorial hospital
Bangkok, Pathum Wan, 10400
Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, 10330
About this study
Official title: The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Acute Upper Gastrointestinal Bleeding: Double-blind Randomized Controlled Trial
The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. The study is aimed to evaluate the efficacy of metoclopramide, as pro-kinetic agent ,for gastric visualization in the patient with acute UGIB; double-blind randomized controlled trial and two centers study. The patient were randomly assigned to receive either metoclopramide (10mg) intravenously or placebo before endoscopy 30-120 min. The primary endpoint was endoscopic yield, assessed by objective gastric visualized scoring systems. Secondary end points include duration of endoscope, technical success rate, the need for second-look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
Read the detailed description
- Double-blind, Double centers, RCT
- All endoscopists at two participating sites attend the pre-study meeting for standardization of protocol and scoring system.
- Eligible patients were randomly assigned to either metoclopramide or placebo group in a 1:1 conceal allocation according to a computer-generated randomization list with block randomization in size of four.
- Assigned treatment was kept in opaque sealed envelopes.
- Before EGD, the patients had adequate resuscitation to maintain stable hemodynamics(SBP ≥ 90 mmHg and/or HR < 100 bpm) and blood transfusion to reach Hb> 7g/dL and correct coagulopathy.
- EGD is performed in left lateral position, under local lidocaine anesthesia alone or combined with IV anesthetics
- The standardized set of endoscopic landmarks, including the esophagus, gastro-esophageal junction, fundus, gastric body, incisura, antrum, duodenal bulb, and second part of the duodenum were examined.
- To assess endoscopic gastric visualization, we applied simple validate objective scoring system and estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb.
- Each location is scored between 0 and 2; Score 0 (worst vision) < 25% of the surface was visible; Score 1 25-75% visible surface; Score 2 (best vision), > 75% visible surface ( total score range 0-8)
- 'Adequate visualization' defined as total score six or higher (out of 8).
- All photos of endoscopic landmark, including the reference endoscopic views of four locations (fundus, corpus antrum and duodenal bulb), were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
- The duration of the endoscopy was recorded from beginning to end of the procedure in minute.
- The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met : I) hematemesis or bloody NG > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR ≥ 110 bpm) or hypotension(SBP ≤ 90 mmHg) after ≥ 1 hour of vital sign stability without other cause; V) hemoglobin drop of ≥ 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) ≥ 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia.
- 30-day rebleeding is accessed by direct phone call to patient.
- Being tested
- Metoclopramide, Normal Saline 10 mL Injection
- Keywords
- Metoclopramide, Acute upper gastrointestinal bleeding, Gastric visualization, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Metoclopramide 10 mg + NSS 10 ml intravenous slowly push in 5min before endoscopy 30-120 min
Normal Saline 10 mL InjectionDrug
Normal saline 10 ml intravenous slowly push in 5min before endoscopy 30-120 min
| Study group | Role | What they receive |
|---|---|---|
| metoclopramide | Experimental | Metoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes. Receives: Drug: Metoclopramide |
| placebo | Placebo comparator | Normal saline 10 ml IV slowly push in 5 minutes. Receives: Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patents with 'adequate visualization'
the efficacy of metoclopramide for gastric visualization by endoscopy in patients with acute upper gastrointestinal bleeding which assess by objective gastric visualized scoring system (score 0-8) ; total score >= 6 consider it as adequate visualization at index EGD
Measured: Though study completion , average 2 yr
Secondary outcomes (7)
mean difference in endoscopic visualized gastric score
score 0-2, including total mean score , and at each location of fundus , corpus , antrum and duodenal bulb
Measured: Though study completion , average 2 yr
duration of endoscopy
duration of endoscopy
Measured: up to 2 hour
immediate hemostasis at index EGD
percentage of succession of procedure by endoscopist for immediate hemostasis of the culprit lesions causing upper gastrointestinal bleeding during index EGD
Measured: Though study completion , average 2 yr
the need of second-look EGD
the need of second-look EGD
Measured: 72 hours
units of red cell transfusion
units of red cell transfusion within 24 hour
Measured: up to 30 days
length of hospital stay
length of hospital stay
Measured: up to 30days
30-day rebleeding rate
30-day rebleeding rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Apr 2021
- Primary completion7 Sep 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Double-blind, Double centers, RCT * The standardized set of endoscopic landmarks, including the esophagus, gastro-esophageal junction, fundus, gastric body, incisura, antrum, duodenal bulb, and second part of the duodenum were examined. * The simple validate objective scoring system was applied; estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb. * Each location was scored between 0 and 2 Score 0 (worst vision), less than 25% of the surface was visible Score 1 25-75% visible surface Score 2 (best vision), more than 75% visible surface ( total score range 0-8) * 'Adequate visualization' = total score six or higher. * All photos was internally validated by another endoscopist who was blinded to the randomization allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771481
- Sponsor's protocol ID
- RP021
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vimonsuntirungsri T, Thungsuk R, Nopjaroonsri P, Faknak N, Pittayanon R. The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial. Am J Gastroenterol. 2024 May 1;119(5):846-855. doi: 10.14309/ajg.0000000000002620. Epub 2023 Dec 7.
PubMed 38059896
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Acute Upper Gastrointestinal Bleeding: Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04771481
- Acronym / sponsor ID
- RP021
- Keywords
- Metoclopramide, Acute upper gastrointestinal bleeding, Gastric visualization, Endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 25 Feb 2021 (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.
The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. The study is aimed to evaluate the efficacy of metoclopramide, as pro-kinetic agent ,for gastric visualization in the patient with acute UGIB; double-blind randomized controlled trial and two centers study. The patient were randomly assigned to receive either metoclopramide (10mg) intravenously or placebo before endoscopy 30-120 min. The primary endpoint was endoscopic yield, assessed by objective gastric visualized scoring systems. Secondary end points include duration of endoscope, technical success rate, the need for second-look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
Detailed description
- Double-blind, Double centers, RCT
- All endoscopists at two participating sites attend the pre-study meeting for standardization of protocol and scoring system.
- Eligible patients were randomly assigned to either metoclopramide or placebo group in a 1:1 conceal allocation according to a computer-generated randomization list with block randomization in size of four.
- Assigned treatment was kept in opaque sealed envelopes.
- Before EGD, the patients had adequate resuscitation to maintain stable hemodynamics(SBP ≥ 90 mmHg and/or HR < 100 bpm) and blood transfusion to reach Hb> 7g/dL and correct coagulopathy.
- EGD is performed in left lateral position, under local lidocaine anesthesia alone or combined with IV anesthetics
- The standardized set of endoscopic landmarks, including the esophagus, gastro-esophageal junction, fundus, gastric body, incisura, antrum, duodenal bulb, and second part of the duodenum were examined.
- To assess endoscopic gastric visualization, we applied simple validate objective scoring system and estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb.
- Each location is scored between 0 and 2; Score 0 (worst vision) < 25% of the surface was visible; Score 1 25-75% visible surface; Score 2 (best vision), > 75% visible surface ( total score range 0-8)
- 'Adequate visualization' defined as total score six or higher (out of 8).
- All photos of endoscopic landmark, including the reference endoscopic views of four locations (fundus, corpus antrum and duodenal bulb), were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
- The duration of the endoscopy was recorded from beginning to end of the procedure in minute.
- The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met : I) hematemesis or bloody NG > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR ≥ 110 bpm) or hypotension(SBP ≤ 90 mmHg) after ≥ 1 hour of vital sign stability without other cause; V) hemoglobin drop of ≥ 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) ≥ 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia.
- 30-day rebleeding is accessed by direct phone call to patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Double-blind, Double centers, RCT * The standardized set of endoscopic landmarks, including the esophagus, gastro-esophageal junction, fundus, gastric body, incisura, antrum, duodenal bulb, and second part of the duodenum were examined. * The simple validate objective scoring system was applied; estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb. * Each location was scored between 0 and 2 Score 0 (worst vision), less than 25% of the surface was visible Score 1 25-75% visible surface Score 2 (best vision), more than 75% visible surface ( total score range 0-8) * 'Adequate visualization' = total score six or higher. * All photos was internally validated by another endoscopist who was blinded to the randomization allocation.
| Arm | Type | Receives |
|---|---|---|
| metoclopramide | Experimental | Drug: MetoclopramideMetoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes. |
| placebo | Placebo comparator | Drug: Normal Saline 10 mL InjectionNormal saline 10 ml IV slowly push in 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years
- Active upper GI bleeding ( defined as fresh or bright red hematemesis within 24hr. or presented of blood via NG aspiration )
- Underwent upper GI endoscopy within 12hr
- Informed consent obtained
Key exclusion criteria (6 listed)
- Known allergy of metoclopramide
- History of gastric or duodenal surgery
- Known case esophageal, gastric or duodenal cancer
- Diagnosed with advanced HIV infection (defined as CD4 cell count <200 cells/mm3 or WHO clinical stage 3 or 4)
- Pregnancy or lactating
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 |
|---|---|---|
| MetoclopramideMetoclopramide 10 mg + NSS 10 ml intravenous slowly push in 5min before endoscopy 30-120 min | Drug | metoclopramide |
| Normal Saline 10 mL InjectionNormal saline 10 ml intravenous slowly push in 5min before endoscopy 30-120 min | Drug | placebo |
Primary outcome
percentage of patents with 'adequate visualization'
Time frame: Though study completion , average 2 yr
the efficacy of metoclopramide for gastric visualization by endoscopy in patients with acute upper gastrointestinal bleeding which assess by objective gastric visualized scoring system (score 0-8) ; total score >= 6 consider it as adequate visualization at index EGD
7 secondary outcomes
mean difference in endoscopic visualized gastric score
Time frame: Though study completion , average 2 yr
duration of endoscopy
Time frame: up to 2 hour
immediate hemostasis at index EGD
Time frame: Though study completion , average 2 yr
the need of second-look EGD
Time frame: 72 hours
units of red cell transfusion
Time frame: up to 30 days
length of hospital stay
Time frame: up to 30days
30-day rebleeding rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 38059896Vimonsuntirungsri T, Thungsuk R, Nopjaroonsri P, Faknak N, Pittayanon R. The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial. Am J Gastroenterol. 2024 May 1;119(5):846-855. doi: 10.14309/ajg.0000000000002620. Epub 2023 Dec 7.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide and Normal Saline 10 mL Injection in people with Acute Upper Gastrointestinal Bleeding and Effect of Drug, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of patents with 'adequate visualization' (time frame: Though study completion , average 2 yr). 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 NCT04771481, which also lists 1 linked publication.
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 2 Oct 2023.