Digestive System DiseasesNCT01378507
Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
A study testing endoscopic submucosal dissection in people with Digestive System Diseases, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Digestive System Diseases
- What is being tested?
- endoscopic submucosal dissection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Apr 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Submucosal tumor
- Mucosal tumor (T1) in patients unsuitable for surgery
Who cannot join
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Insufficient access to tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jin Huang, M.D., lily712@vip.sina.com
Zhong-Sheng Lu, M.D.
About this study
Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.
Read the detailed description
Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.
- Conditions
- Digestive System Diseases
- Being tested
- endoscopic submucosal dissection
- Keywords
- endoscopic submucosal dissection, gastrointestinal neoplasm
- Medical subject headings
- Digestive System Diseases, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal dissectionBehavioural
Also called Endoscopic Submucosal Dissection(ESD)
ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Submucosal Dissection | Experimental | Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection Receives: Behavioral: endoscopic submucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The lesion result before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Measured: within 7 days before ESD
Short-term result after ESD
Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
Measured: whithin 7 days after ESD
Secondary outcomes (1)
The safety of ESD procedure
including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Measured: 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionJun 2011 (estimated)
- Study completionApr 2013 (estimated)
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 Digestive System DiseasesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zhong-Sheng Lu, M.D., Study chair, Chinese PLA General HospitalYun-Sheng Yang, M.D., Study director, Chinese PLA General HospitalJin Huang, M.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378507
- Sponsor's protocol ID
- 20110526004
- Status last verified
- May 2011
- First submitted
- 20 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
PubMed 26078575
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
- ClinicalTrials.gov ID
- NCT01378507
- Acronym / sponsor ID
- 20110526004
- Conditions
- Digestive System Diseases
- Keywords
- endoscopic submucosal dissection, gastrointestinal neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 22 Jun 2011 (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.
Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.
Detailed description
Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Submucosal Dissection | Experimental | Behavioral: endoscopic submucosal dissectionSingle-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Submucosal tumor
- Mucosal tumor (T1) in patients unsuitable for surgery
Key exclusion criteria (2 listed)
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Insufficient access to tumor
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 |
|---|---|---|
| endoscopic submucosal dissectionAlso: Endoscopic Submucosal Dissection(ESD)ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection. | Behavioural | Endoscopic Submucosal Dissection |
Primary outcome
The lesion result before ESD
Time frame: within 7 days before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result after ESD
Time frame: whithin 7 days after ESD
Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
1 secondary outcome
The safety of ESD procedure
Time frame: 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Derived from this study: PubMed 26078575Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
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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.
Zhong-Sheng Lu, M.D. study chair
Chinese PLA General Hospital
Yun-Sheng Yang, M.D. study director
Chinese PLA General Hospital
Jin Huang, M.D. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic submucosal dissection in people with Digestive System Diseases, run by Chinese PLA General 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 2 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 22 Jun 2011. 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?
Contact Zhong-Sheng Lu, M.D. (86-10-66937467, lzs936150@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The lesion result before ESD (time frame: within 7 days before ESD). 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?
On the ClinicalTrials.gov record for NCT01378507, 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 22 Jun 2011.