Esophageal VaricesNCT02361593
Transparent Cap-assisted Endoscopic Sclerotherapy
A study testing assistance of a transparent cap and without a transparent cap in people with Esophageal Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- assistance of a transparent cap and without a transparent cap
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2016
- 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 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presented to our hospital with esophageal varices diagnosed by gastroscopy, with or without gastric varices.
- The age of the patients range from 18 to 80 years old.
Who cannot join
- Patients who have contraindications for lauromacrogol therapy or transparent cap.
- Patients who have no previous upper gastrointestinal bleeding history.
- Patients who have fecal disease that could greatly impact survival, such as uremia, advanced cancer or respiratory failure, et al.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.
Read the detailed description
Endoscopic procedures now play a great role in management of esophagogastric varices. Endoscopic variceal ligation(EVL) was recommended as first line therapy for primary and secondary prophylaxis in patients with esophageal varices. Previous studies have showed a superiority of EVL over endoscopic injection of sclerotherapy(EIS), mainly because of lower occurrence rate of complications. Procedure related complications were related to total amount of lauromacrogol, number of treatment and expertise of the endoscopists. Transparent cap has already been reported to assist in other endoscopic procedures, such as biopsy of Barret esophagus or endoscopic submucosal dissection. Accuracy and vision were improved with the help of transparent cap in the front of endoscopy. We have tried transparent cap-assisted sclerotherapy in some patients with in our hospital. Now a randomized controlled trial was conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapy in management of esophageal varices.
- Conditions
- Esophageal Varices
- Being tested
- assistance of a transparent cap, without a transparent cap
- Keywords
- endoscopic sclerotherapy, esophageal varices, transparent cap
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assistance of a transparent capProcedure or surgery
Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
without a transparent capProcedure or surgery
Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
| Study group | Role | What they receive |
|---|---|---|
| Cap group | Experimental | Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy. Receives: Procedure: assistance of a transparent cap |
| Control group | Active comparator | Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved). Receives: Procedure: without a transparent cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding rate
Rebleeding was defined as melena or hematemasis
Measured: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Secondary outcomes (4)
incidence rate of complications
Participants will be followed for up to 1 month starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain.
Measured: From date of randomization until 1 month after randomization
mortality rate
Patients will be followed up for 1 month and all-cause death will be recorded.
Measured: From date of randomization until the date of death, assessed up to 1 month
time consumption of the procedure
Measured: From the beginning of the endoscopic injection until the end of the procedure.
occurrence rate of bleeding during the procedure
Bleeding was defined as visible errhysis seen from gastroscopy
Measured: From the beginning of the endoscopic injection, until the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao CHEN, M.D., Study director, Zhongshan Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361593
- Sponsor's protocol ID
- CAP-VARICE
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2015
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transparent Cap-assisted Endoscopic Sclerotherapy(Lauromacrogol Injection) in Esophageal Varices: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02361593
- Acronym / sponsor ID
- CAP-VARICE
- Conditions
- Esophageal Varices
- Keywords
- endoscopic sclerotherapy, esophageal varices, transparent cap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Feb 2015 (estimated)
- 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 aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.
Detailed description
Endoscopic procedures now play a great role in management of esophagogastric varices. Endoscopic variceal ligation(EVL) was recommended as first line therapy for primary and secondary prophylaxis in patients with esophageal varices. Previous studies have showed a superiority of EVL over endoscopic injection of sclerotherapy(EIS), mainly because of lower occurrence rate of complications. Procedure related complications were related to total amount of lauromacrogol, number of treatment and expertise of the endoscopists. Transparent cap has already been reported to assist in other endoscopic procedures, such as biopsy of Barret esophagus or endoscopic submucosal dissection. Accuracy and vision were improved with the help of transparent cap in the front of endoscopy. We have tried transparent cap-assisted sclerotherapy in some patients with in our hospital. Now a randomized controlled trial was conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapy in management of esophageal varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap group | Experimental | Procedure: assistance of a transparent capPatients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy. |
| Control group | Active comparator | Procedure: without a transparent capPatients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved). |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presented to our hospital with esophageal varices diagnosed by gastroscopy, with or without gastric varices.
- The age of the patients range from 18 to 80 years old.
Key exclusion criteria (3 listed)
- Patients who have contraindications for lauromacrogol therapy or transparent cap.
- Patients who have no previous upper gastrointestinal bleeding history.
- Patients who have fecal disease that could greatly impact survival, such as uremia, advanced cancer or respiratory failure, et al.
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 |
|---|---|---|
| assistance of a transparent capPatients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap. | Procedure or surgery | Cap group |
| without a transparent capPatients will receive routine endoscopic injection of lauromacrogol without use of transparent cap. | Procedure or surgery | Control group |
Primary outcome
rebleeding rate
Time frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month
Rebleeding was defined as melena or hematemasis
4 secondary outcomes
incidence rate of complications
Time frame: From date of randomization until 1 month after randomization
mortality rate
Time frame: From date of randomization until the date of death, assessed up to 1 month
time consumption of the procedure
Time frame: From the beginning of the endoscopic injection until the end of the procedure.
occurrence rate of bleeding during the procedure
Time frame: From the beginning of the endoscopic injection, until the end of the procedure.
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 16 Jan 2017.
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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.
Shiyao CHEN, M.D. study director
Zhongshan Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assistance of a transparent cap and without a transparent cap in people with Esophageal Varices, run by Shanghai Zhongshan 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 2 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: finished, as of the sponsor's last update on 16 Jan 2017. 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?
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?
rebleeding rate (time frame: From date of randomization until the date of first rebleeding episode, assessed up to 1 month). 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 16 Jan 2017.