Esophageal CancerNCT01760070
Comparison of O-type Hybrid Knife and IT Knife in ESD
A study testing Hybrid knife and IT knife in people with Esophageal Cancer and Esophageal Dysplasia, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Esophageal Dysplasia, Stomach Cancer
- What is being tested?
- Hybrid knife and IT knife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
- The patients who agreed informed consent
Who cannot join
- Recent drug history of anticoagulant or antiplatelet agent within 7 days
- Recurrent gastric or esophageal adenoma or early cancer
- Pregnant or breast feeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
Read the detailed description
Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.
- Being tested
- Hybrid knife, IT knife
- Keywords
- cancer, endoscopy, endoscopic submucosal dissection
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid knifeDevice
Use Hybrid knife in ESD procedure
IT knifeDevice
Use IT knife in ESD procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid knife | Experimental | O-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting. Receives: Device: Hybrid knife |
| IT knife | Active comparator | IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting. Receives: Device: IT knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time for ESD
The time to finish the whole ESD procedure.
Measured: up to 1 day
Secondary outcomes (3)
Submucosal dissection time
The time for submucosal dissection of ESD
Measured: up to 1 day
Perforation rate
The perforation rate of ESD during and after procedure.
Measured: up to 7 day
Bleeding Rate
The bleeding rate of ESD during and after procedure.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, Principal investigator, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760070
- Sponsor's protocol ID
- XIJINGHDD-20121227-01
- Status last verified
- Jan 2015
- First submitted
- 28 Dec 2012
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.
PubMed 19343433Fukami N, Ryu CB, Said S, Weber Z, Chen YK. Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study. Gastrointest Endosc. 2011 Jun;73(6):1246-53. doi: 10.1016/j.gie.2010.12.004. Epub 2011 Feb 12.
PubMed 21316668
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01760070
- Acronym / sponsor ID
- XIJINGHDD-20121227-01
- Keywords
- cancer, endoscopy, endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jan 2013 (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.
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
Detailed description
Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid knife | Experimental | Device: Hybrid knifeO-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting. |
| IT knife | Active comparator | Device: IT knifeIT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
- The patients who agreed informed consent
Key exclusion criteria (3 listed)
- Recent drug history of anticoagulant or antiplatelet agent within 7 days
- Recurrent gastric or esophageal adenoma or early cancer
- Pregnant or breast feeding patients.
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 |
|---|---|---|
| Hybrid knifeUse Hybrid knife in ESD procedure | Device | Hybrid knife |
| IT knifeUse IT knife in ESD procedure. | Device | IT knife |
Primary outcome
Procedure time for ESD
Time frame: up to 1 day
The time to finish the whole ESD procedure.
3 secondary outcomes
Submucosal dissection time
Time frame: up to 1 day
Perforation rate
Time frame: up to 7 day
Bleeding Rate
Time frame: up to 7 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 26 Jan 2015.
- Background: PubMed 19343433Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.
- Background: PubMed 21316668Fukami N, Ryu CB, Said S, Weber Z, Chen YK. Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study. Gastrointest Endosc. 2011 Jun;73(6):1246-53. doi: 10.1016/j.gie.2010.12.004. Epub 2011 Feb 12.
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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.
Zhiguo Liu principal investigator
Xijing Hospital of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid knife and IT knife in people with Esophageal Cancer and Esophageal Dysplasia, run by Xijing Hospital of Digestive Diseases 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 26 Jan 2015. 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?
Procedure time for ESD (time frame: up to 1 day). 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 NCT01760070, which also lists 2 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 26 Jan 2015.