Anastomotic LeakageNCT01696682
The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
A study testing Narrowed Gastric Conduit and Widened Gastric Conduit in people with Anastomotic Leakage, run by Fudan University at 1 site in China.
Trial summary
The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anastomotic Leakage
- What is being tested?
- Narrowed Gastric Conduit and Widened Gastric Conduit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent minimally invasive esophagectomy(three-hole procedure)
- Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy
Who cannot join
- With previous cancer history
- Severe Co-morbidity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Thoracic Surgery, Zhongshan Hospital of Fudan University
Shanghai, 200032
Yaxing Shen, MD, 86-13661983366, shen.yaxing@zs-hospital.sh.cn
Hao Wang, MD
About this study
Official title: Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.
Read the detailed description
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.
- Conditions
- Anastomotic Leakage
- Being tested
- Narrowed Gastric Conduit, Widened Gastric Conduit
- Keywords
- minimally invasive esophagectomy, anastomotic leakage, gastric conduit
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowed Gastric ConduitProcedure or surgery
Also called Narrowed Gastric Tube
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
Widened Gastric ConduitProcedure or surgery
Also called Wide Gastric Tube
A widened gastric tube will be formed during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Narrow Gastric Conduit | Experimental | The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy Receives: Procedure: Narrowed Gastric Conduit |
| Wide Gastric Conduit | Experimental | The group in which widened gastric conduit will be performed during minimally invasive esophagectomy Receives: Procedure: Widened Gastric Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anastomotic leakage rate
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
Measured: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakageStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan, Lijie, Fudan University
- Investigators
- Lijie Tan, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696682
- Sponsor's protocol ID
- ZSchest2012001
- Status last verified
- Feb 2013
- First submitted
- 22 Sep 2012
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT01696682
- Acronym / sponsor ID
- ZSchest2012001
- Conditions
- Anastomotic Leakage
- Keywords
- minimally invasive esophagectomy, anastomotic leakage, gastric conduit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Oct 2012 (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 study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.
Detailed description
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow Gastric Conduit | Experimental | Procedure: Narrowed Gastric ConduitThe group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy |
| Wide Gastric Conduit | Experimental | Procedure: Widened Gastric ConduitThe group in which widened gastric conduit will be performed during minimally invasive esophagectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients underwent minimally invasive esophagectomy(three-hole procedure)
- Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy
Key exclusion criteria (2 listed)
- With previous cancer history
- Severe Co-morbidity
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 |
|---|---|---|
| Narrowed Gastric ConduitAlso: Narrowed Gastric TubeThe gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy | Procedure or surgery | Narrow Gastric Conduit |
| Widened Gastric ConduitAlso: Wide Gastric TubeA widened gastric tube will be formed during the surgery | Procedure or surgery | Wide Gastric Conduit |
Primary outcome
The anastomotic leakage rate
Time frame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
Lijie Tan, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrowed Gastric Conduit and Widened Gastric Conduit in people with Anastomotic Leakage, run by Fudan University 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 11 Feb 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 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 Yaxing Shen, MD (86-13661983366, SHEN.YAXING@ZS-HOSPITAL.SH.CN), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The anastomotic leakage rate (time frame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 11 Feb 2013.