Rectal CancerELAPENCT02036112
Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer
A study testing conventional ELAPE and Individual ELAPE in people with Rectal Cancer, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- conventional ELAPE and Individual ELAPE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor within 5 cm of the anal verge or with a very narrow pelvis
- T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
- Absence of distant metastases
- Absence of intestinal obstruction
Who cannot join
- T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
- With distant metastases
- With intestinal obstruction
- Pregnancy or lactation
- Allergic constitution to heterogeneous protein
- With operation contraindication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Jiagang Han, Professor, 8613522867841, hjg211@163.com
Jiagang Han, Professor
About this study
Official title: Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.
Read the detailed description
We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left
. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.
- Conditions
- Rectal Cancer
- Being tested
- conventional ELAPE, Individual ELAPE
- Keywords
- Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ELAPEProcedure or surgery
device
Individual ELAPEProcedure or surgery
device
| Study group | Role | What they receive |
|---|---|---|
| Individual ELAPE | Experimental | Patients will receive Individual ELAPE technique Receives: Procedure: Individual ELAPE |
| Conventional ELAPE | Experimental | Patients with advanced lower rectal cancer will receive conventional EALPE technique Receives: Procedure: conventional ELAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perioperative morbidity
Sexual dysfunction,Urinary retention，Chronic perineal pain，Perineal wound infection，Urinary system infection，Pulmonary infection，Perineal seroma，Peristomal hernia，Abdominal wound infection，Perineal herniation
Measured: three years
Secondary outcomes (1)
Three years survival postoperatively
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Jiagang Han, Professor, Study director, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036112
- Sponsor's protocol ID
- IELAPE1127
- Acronym
- ELAPE
- Status last verified
- Jan 2014
- First submitted
- 26 Nov 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Han JG, Wang ZJ, Wei GH, Gao ZG, Yang Y, Zhao BC. Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg. 2012 Sep;204(3):274-82. doi: 10.1016/j.amjsurg.2012.05.001.
PubMed 22920402
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
- ClinicalTrials.gov ID
- NCT02036112
- Acronym / sponsor ID
- ELAPE / IELAPE1127
- Conditions
- Rectal Cancer
- Keywords
- Advanced Lower rectal cancer, Extralevator abdominoperineal excision, Circumferential resection margin, Morbidity, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 14 Jan 2014 (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.
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.
Detailed description
We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left
. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual ELAPE | Experimental | Procedure: Individual ELAPEPatients will receive Individual ELAPE technique |
| Conventional ELAPE | Experimental | Procedure: conventional ELAPEPatients with advanced lower rectal cancer will receive conventional EALPE technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tumor within 5 cm of the anal verge or with a very narrow pelvis
- T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
- Absence of distant metastases
- Absence of intestinal obstruction
Key exclusion criteria (6 listed)
- T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
- With distant metastases
- With intestinal obstruction
- Pregnancy or lactation
- Allergic constitution to heterogeneous protein
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 |
|---|---|---|
| conventional ELAPEdevice | Procedure or surgery | Conventional ELAPE |
| Individual ELAPEdevice | Procedure or surgery | Individual ELAPE |
Primary outcome
The perioperative morbidity
Time frame: three years
Sexual dysfunction,Urinary retention，Chronic perineal pain，Perineal wound infection，Urinary system infection，Pulmonary infection，Perineal seroma，Peristomal hernia，Abdominal wound infection，Perineal herniation
1 secondary outcome
Three years survival postoperatively
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 22920402Han JG, Wang ZJ, Wei GH, Gao ZG, Yang Y, Zhao BC. Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg. 2012 Sep;204(3):274-82. doi: 10.1016/j.amjsurg.2012.05.001.
- Related InfoLink provided by the sponsor.
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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.
Jiagang Han, Professor study director
Beijing Chao Yang 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 conventional ELAPE and Individual ELAPE in people with Rectal Cancer, run by Beijing Chao Yang 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 4 inclusion and 6 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 14 Jan 2014. 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 Jiagang Han, Professor (8613522867841, hjg211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perioperative morbidity (time frame: three years). 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 NCT02036112, 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 14 Jan 2014.