Colorectal NeoplasmsDISSECMUCNCT01879904
Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
A study testing Endoscopic submucosal dissection (ESD) in people with Colorectal Neoplasms and Endoscopic Submucosal Dissection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Neoplasms, Endoscopic Submucosal Dissection
- What is being tested?
- Endoscopic submucosal dissection (ESD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jul 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with superficial medium or distal rectal tumors more than 1 cm in size
- Criteria for ESD were determined by the endoscopic characteristics and histological findings of biopsy specimens
- Endoscopic ultrasonography (EUS) also was performed when the lesion was strongly suspected of submucosal invasion.
- Age older than 18, younger than 85 years.
Who cannot join
- Lesion less than 10 mm in size
- Pedundulated lesion
- Suspicion of submucosal invasion (MRI or EUS)
- Distant metastasis on CTscan
- Coagulopathy
- Pregnancy
- Refusal to participate to the study or inability to consent
Trial locations and contacts
1 site in 1 country.
France1 site
Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75015
About this study
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. This technique is actually performed routinely in Japan and experience is limited in Europe, with few data in the literature.
This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
Read more
Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed.
All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies):
- For complete resection, an endoscopic control was performed at 1 year.
- For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year.
At one year, patient with incomplete resection have a surgical resection.
Read the detailed description
Colorectal neoplasia prevalence was 35 000 for a total number of 278 000 cancers in France during 2000. Treatment of these cancers is based on local extension especially in the digestive tract (stade) and on co-morbidities of the patient. There are many advantages to treat these cancers at an early stade (involving mucosa or superficial submucosa), since they are associated with a better prognosis with a lower cost-effectivness ratio. Indeed, in 2003 mean cost of treatment of colorectal cancer during the first year following diagnosis was 24 000 €, whereas it was only 18 000 € for early stade and up to 36 000 € for the most advanced stade. Transversal (1 week) and national survey of the French society of endoscopy (SFED) during 8 years demonstrated that among 1 millions of endoscopies (3/4 being performed with anesthesia), 8000 were performed for endosocpic treatment of early digestive cancers by endoscopic mucosal resection (EMR) or more recently by endoscopic submucosal dissection (ESD). One of the problems to diffuse these endoscopic treatments is the multiple tools required to endotherapy, and the fact that this treatment is time-consuming, whereas a simple ablation of polyps (polypectomy) smaller than 1.5 cm needs only 5 to 10 minutes. For exemple, endotherapeutic tools for polypectomy (one needle and one polypectomy loop) costs 180 € and occasionally required a couple of clips when rare (1%) hemorrhage or exceptional (1p1000) perforation occurred. Conversely, endotherapy tools for ESD of early mucosal or submucosal digestive cancers larger than 1.5 cm up to 4-5 cm, costs 1500 €, including needles, submucosal injected products, hook-knife, insulinated-knife and coagulation rasper. So, the recent T2A codification gathers these two kinds of endoscopic treatment under the same code, whatever the size of the lesion, whereas costs of tools required for their treatment are notably different especially when there are performed for inpatients hospitalized less that 2 days which is only charged 480 € added of 192 € and 53€ for salary in private exercise or 914 € in public hospital, by the national and public healthcare system. Beside the expertise required for EMR and ESD of larger early cancers, this cost does not invite to increase the frequency of EMR or ESD, taking into account that this treatment is better practised by two simultaneous endoscopists, one of them manipulating the endoscope en endotherapy tools.
- Being tested
- Endoscopic submucosal dissection (ESD)
- Keywords
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissection (ESD)Procedure or surgery
Also called endoscopic submucosal dissection
This study is suggest to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | Experimental | Endoscopic submucosal dissection (ESD) Receives: Procedure: Endoscopic submucosal dissection (ESD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
curative resection rate (3 month)
Evaluate the curative R0 resection rate at 3 months without surgical therapy, in patients with superficial rectal tumours
Measured: 3 months
Secondary outcomes (4)
monobloc resection rate
evaluate the monobloc resection rate
Measured: 1 year
complication rate
evaluate the complication rate
Measured: 1 year
complete resection predictive factors
evaluate the complete resection predictive factors
Measured: 1 year
Curative resection rate (1 year)
Evaluate the curative R0 resection rate at 1 year without surgical therapy, in patients with superficial rectal tumours
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startFeb 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Cellier, PD, PhD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879904
- Sponsor's protocol ID
- P081202
- Acronym
- DISSECMUC
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy
- ClinicalTrials.gov ID
- NCT01879904
- Acronym / sponsor ID
- DISSECMUC / P081202
- Keywords
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jun 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.
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. This technique is actually performed routinely in Japan and experience is limited in Europe, with few data in the literature.
This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed.
All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies):
- For complete resection, an endoscopic control was performed at 1 year.
- For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year.
At one year, patient with incomplete resection have a surgical resection.
Detailed description
Colorectal neoplasia prevalence was 35 000 for a total number of 278 000 cancers in France during 2000. Treatment of these cancers is based on local extension especially in the digestive tract (stade) and on co-morbidities of the patient. There are many advantages to treat these cancers at an early stade (involving mucosa or superficial submucosa), since they are associated with a better prognosis with a lower cost-effectivness ratio. Indeed, in 2003 mean cost of treatment of colorectal cancer during the first year following diagnosis was 24 000 €, whereas it was only 18 000 € for early stade and up to 36 000 € for the most advanced stade. Transversal (1 week) and national survey of the French society of endoscopy (SFED) during 8 years demonstrated that among 1 millions of endoscopies (3/4 being performed with anesthesia), 8000 were performed for endosocpic treatment of early digestive cancers by endoscopic mucosal resection (EMR) or more recently by endoscopic submucosal dissection (ESD). One of the problems to diffuse these endoscopic treatments is the multiple tools required to endotherapy, and the fact that this treatment is time-consuming, whereas a simple ablation of polyps (polypectomy) smaller than 1.5 cm needs only 5 to 10 minutes. For exemple, endotherapeutic tools for polypectomy (one needle and one polypectomy loop) costs 180 € and occasionally required a couple of clips when rare (1%) hemorrhage or exceptional (1p1000) perforation occurred. Conversely, endotherapy tools for ESD of early mucosal or submucosal digestive cancers larger than 1.5 cm up to 4-5 cm, costs 1500 €, including needles, submucosal injected products, hook-knife, insulinated-knife and coagulation rasper. So, the recent T2A codification gathers these two kinds of endoscopic treatment under the same code, whatever the size of the lesion, whereas costs of tools required for their treatment are notably different especially when there are performed for inpatients hospitalized less that 2 days which is only charged 480 € added of 192 € and 53€ for salary in private exercise or 914 € in public hospital, by the national and public healthcare system. Beside the expertise required for EMR and ESD of larger early cancers, this cost does not invite to increase the frequency of EMR or ESD, taking into account that this treatment is better practised by two simultaneous endoscopists, one of them manipulating the endoscope en endotherapy tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | Experimental | Procedure: Endoscopic submucosal dissection (ESD)Endoscopic submucosal dissection (ESD) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with superficial medium or distal rectal tumors more than 1 cm in size
- Criteria for ESD were determined by the endoscopic characteristics and histological findings of biopsy specimens
- Endoscopic ultrasonography (EUS) also was performed when the lesion was strongly suspected of submucosal invasion.
- Age older than 18, younger than 85 years.
Key exclusion criteria (7 listed)
- Lesion less than 10 mm in size
- Pedundulated lesion
- Suspicion of submucosal invasion (MRI or EUS)
- Distant metastasis on CTscan
- Coagulopathy
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 dissection (ESD)Also: endoscopic submucosal dissectionThis study is suggest to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure. | Procedure or surgery | Endoscopic submucosal dissection (ESD) |
Primary outcome
curative resection rate (3 month)
Time frame: 3 months
Evaluate the curative R0 resection rate at 3 months without surgical therapy, in patients with superficial rectal tumours
4 secondary outcomes
monobloc resection rate
Time frame: 1 year
complication rate
Time frame: 1 year
complete resection predictive factors
Time frame: 1 year
Curative resection rate (1 year)
Time frame: 1 year
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 18 Sep 2013.
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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.
Christophe Cellier, PD, PhD principal investigator
Hôpital Européen Georges-Pompidou
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 (ESD) in people with Colorectal Neoplasms and Endoscopic Submucosal Dissection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 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 18 Sep 2013. 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 France. 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?
curative resection rate (3 month) (time frame: 3 months). 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 18 Sep 2013.