Colonic CancerNCT02585271
Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction
A study testing Transanal decompression tube and Stent in people with Colonic Cancer and Rectal Cancer, run by Xuzhou Central Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Cancer, Rectal Cancer
- What is being tested?
- Transanal decompression tube and Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2015to 1 Jun 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
- definite diagnosis of left-side colonic or rectal obstruction;
- symptomatic colonic obstruction for less than 1 week;
- colonic obstruction caused by a histologically proven malignant colonic tumor
Who cannot join
- suspected benign colonic or rectal obstruction;
- right-side colonic obstruction;
- patients with signs of peritonitis;
- dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
- patients who do not want to undergo surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction
The purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
Read the detailed description
Approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. Left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. Emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. Preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. Both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. Investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
- Conditions
- Colonic Cancer, Rectal Cancer
- Being tested
- Transanal decompression tube, Stent
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal decompression tubeDevice
22 Fr transanal decompression tube
StentDevice
self-expandable colorectal nitinol alloys stent
| Study group | Role | What they receive |
|---|---|---|
| Transanal decompression tube | Other | Patients undergo placement of the transanal decompression tube as a bridge to surgery Receives: Device: Transanal decompression tube |
| Stent | Other | Patients undergo placement of the stent as a bridge to surgery Receives: Device: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of stoma
Creation of stoma include temporary and definitive stoma.
Measured: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Secondary outcomes (3)
Transanal decompression tube/stent-related complications
Transanal decompression tube/stent-related complications usually include bowel perforation, migration, and stent re-obstruction.
Measured: From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
Surgery-related complications
Surgery-related complications usually include wound complications and anastomotic leak.
Measured: From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Overall survival
Measured: From the date of randomization until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Why it stopped: We can not get enough sample size.
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 Colonic 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Song, MD, Study director, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585271
- Sponsor's protocol ID
- 46650455-0
- Status last verified
- Jul 2019
- First submitted
- 21 Oct 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Xu YS, Song T, Guo YT, Shao GQ, Du HT, Li DC, Fu YF. Placement of the Decompression Tube as a Bridge to Surgery for Acute Malignant Left-Sided Colonic Obstruction. J Gastrointest Surg. 2015 Dec;19(12):2243-8. doi: 10.1007/s11605-015-2936-7. Epub 2015 Sep 9.
PubMed 26354721
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Decompression Tube Versus Stent as a Bridge to Surgery for Acute Malignant Left-sided Colonic and Rectal Obstruction
- ClinicalTrials.gov ID
- NCT02585271
- Acronym / sponsor ID
- 46650455-0
- Conditions
- Colonic Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We can not get enough sample size.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 23 Oct 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 purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
Detailed description
Approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. Left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. Emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. Preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. Both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. Investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal decompression tube | Other | Device: Transanal decompression tubePatients undergo placement of the transanal decompression tube as a bridge to surgery |
| Stent | Other | Device: StentPatients undergo placement of the stent as a bridge to surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- definite diagnosis of left-side colonic or rectal obstruction;
- symptomatic colonic obstruction for less than 1 week;
- colonic obstruction caused by a histologically proven malignant colonic tumor
Key exclusion criteria (5 listed)
- suspected benign colonic or rectal obstruction;
- right-side colonic obstruction;
- patients with signs of peritonitis;
- dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
- patients who do not want to undergo surgery.
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 |
|---|---|---|
| Transanal decompression tube22 Fr transanal decompression tube | Device | Transanal decompression tube |
| Stentself-expandable colorectal nitinol alloys stent | Device | Stent |
Primary outcome
Creation of stoma
Time frame: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months
Creation of stoma include temporary and definitive stoma.
3 secondary outcomes
Transanal decompression tube/stent-related complications
Time frame: From the date of randomization until the date of first documented transanal decompression tube/stent-related complication, assessed up to 7 days
Surgery-related complications
Time frame: From the date of randomization until the date of first documented surgery-related complication, assessed up to 24 months
Overall survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 24 months
Results and safety
The study was stopped early (reason given: We can not get enough sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 26354721Xu YS, Song T, Guo YT, Shao GQ, Du HT, Li DC, Fu YF. Placement of the Decompression Tube as a Bridge to Surgery for Acute Malignant Left-Sided Colonic Obstruction. J Gastrointest Surg. 2015 Dec;19(12):2243-8. doi: 10.1007/s11605-015-2936-7. Epub 2015 Sep 9.
- Individual participant dataSharing planned: No
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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.
Tao Song, MD study director
Xuzhou Central 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 Transanal decompression tube and Stent in people with Colonic Cancer and Rectal Cancer, run by Xuzhou Central 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jul 2019. 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 was stopped early (reason given: We can not get enough sample size.). Results are not available in the source record.
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?
Creation of stoma (time frame: From the date of randomization until the date of first documented creation of stoma, assessed up to 24 months). 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 NCT02585271, 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 5 Jul 2019.