Emergency HemostasisNCT05165043
Position Changes in Cirrhosis Hemorrhagic Spot Detection
An observational study of Emergency Hemostasis, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Hemostasis
- What is being tested?
- position change
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 30 Jan 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included.
Who may be able to join
- conducted position change due to massive EGVB resulting in poor visualization in the stomach
Who cannot join
- incomplete information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Position Changes in Endoscopic Cirrhosis Variceal Hemorrhagic Spot Detection: a Retrospective Study of 11 Cases
The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.
Read the detailed description
The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.
The gastroscopes procedure was started in the left lateral position in all patients. Bleeding varices detected before the position change were stopped by the endoscopic hemostatic measures described above. The following conditions would consider a change of position during gastroscopy: (1) A large amount of blood or blood clot was found after reaching the stomach, making it difficult to suction adequately which led to poor mucosal visuality; (2) Persistent massive bleeding from a blood vessel that filled the stomach cavity rapidly after suction, making it impossible to clarify the bleeding vessel.During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change.
Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu).
- Conditions
- Emergency Hemostasis
- Being tested
- position change
- Keywords
- Complications of cirrhosis, Variceal bleeding, Position change, Emergency hemostasis, Rebleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
position changeProcedure or surgery
The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included,patients changed from the left lateral position to the right lateral position.
| Study group | Role | What they receive |
|---|---|---|
| PC group | The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.
During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change.
Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu). Receives: Procedure: position change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of successful hemostasis
non-rebleeding within 5 days after treatment
Measured: within 5 days
Incidence of rebleeding
early rebleeding
Measured: within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start30 Dec 2021 (estimated)
- Primary completion5 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency HemostasisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165043
- Sponsor's protocol ID
- PC-1.0
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position Changes in Endoscopic Cirrhosis Variceal Hemorrhagic Spot Detection: a Retrospective Study of 11 Cases
- ClinicalTrials.gov ID
- NCT05165043
- Acronym / sponsor ID
- PC-1.0
- Conditions
- Emergency Hemostasis
- Keywords
- Complications of cirrhosis, Variceal bleeding, Position change, Emergency hemostasis, Rebleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 5 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 21 Dec 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 patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.
Detailed description
The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.
The gastroscopes procedure was started in the left lateral position in all patients. Bleeding varices detected before the position change were stopped by the endoscopic hemostatic measures described above. The following conditions would consider a change of position during gastroscopy: (1) A large amount of blood or blood clot was found after reaching the stomach, making it difficult to suction adequately which led to poor mucosal visuality; (2) Persistent massive bleeding from a blood vessel that filled the stomach cavity rapidly after suction, making it impossible to clarify the bleeding vessel.During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change.
Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PC group | – | Procedure: position changeThe patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information. During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change. Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included.
Key inclusion criteria (1 listed)
- conducted position change due to massive EGVB resulting in poor visualization in the stomach
Key exclusion criteria (1 listed)
- incomplete information
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 |
|---|---|---|
| position changeThe patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included,patients changed from the left lateral position to the right lateral position. | Procedure or surgery | PC group |
Primary outcome
Incidence of successful hemostasis
Time frame: within 5 days
non-rebleeding within 5 days after treatment
Incidence of rebleeding
Time frame: within 5 days
early rebleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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?
An observational study of Emergency Hemostasis, run by Ningbo No. 1 Hospital at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. 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 China. 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?
Results are not available in the source record.
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?
Incidence of successful hemostasis (time frame: within 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.