Esophageal NeoplasmsNCT02703142
Endoscopic Evaluation After Esophagectomy
An observational study of Esophageal Neoplasms and Constriction, run by Nagasaki University at 1 site in Japan.
Trial summary
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Esophageal Neoplasms, Constriction, Anastomotic Leak
- What is being tested?
- Patients after esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2015to Oct 2016
- Phase
- Observational
- 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 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.
Who may be able to join
- Malignant or end-stage benign esophageal disease.
- Esophagectomy with reconstruction by a gastric pull-up.
Who cannot join
- Severe heart failure and pulmonary dysfunction
- Severe renal and liver dysfunction
- Allergenic history
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
Read the detailed description
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. However the evaluation and prevention before developing gastric conduit ischemia have been established. The investigators have built a hypothesis that the evaluation for gastric mucosal ischemia in early phase after esophagectomy predict the complication of gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
- Conditions
- Esophageal Neoplasms, Constriction, Anastomotic Leak, Ischemia
- Being tested
- Patients after esophagectomy
- Keywords
- esophagogastrostomy, gastric conduit ischemia, endoscopy
- Medical subject headings
- Esophageal Neoplasms, Constriction, Pathologic, Anastomotic Leak, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients after esophagectomyProcedure or surgery
postoperative endoscopic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Patients after esophagectomy | Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated. Receives: Procedure: Patients after esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
Measured: From 1 to 29 days after esophagectomy
Number of participants with the classification of gastric conduit ischemia by endoscopic findings
Measured: From 1 to 15 days after esophagectomy
Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)
Measured: From 1 to 29 days after esophagectomy
Secondary outcomes (3)
Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number
Measured: From 1 to 29 days after esophagectomy
Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining
The scoring system refer to the article entitled a scoring system for immunohistochemical staining: consensus report of the task force for basic research of the EORTC-GCCG. European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group (J Clin Pathol. 1997 Oct; 50(10): 801-804.)
Measured: From 1 to 29 days after esophagectomy
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
Measured: From 1 to 29 days after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kobayashi Shinichiro, Nagasaki University
- Investigators
- Shinichiro Kobayashi, Study director, Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703142
- Sponsor's protocol ID
- NagasakiU
- Status last verified
- Oct 2016
- First submitted
- 18 Jan 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction
- ClinicalTrials.gov ID
- NCT02703142
- Acronym / sponsor ID
- NagasakiU
- Conditions
- Esophageal Neoplasms, Constriction, Anastomotic Leak, Ischemia
- Keywords
- esophagogastrostomy, gastric conduit ischemia, endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Mar 2016 (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.
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
Detailed description
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. However the evaluation and prevention before developing gastric conduit ischemia have been established. The investigators have built a hypothesis that the evaluation for gastric mucosal ischemia in early phase after esophagectomy predict the complication of gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after esophagectomy | – | Procedure: Patients after esophagectomyEndoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated. |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.
Key inclusion criteria (2 listed)
- Malignant or end-stage benign esophageal disease.
- Esophagectomy with reconstruction by a gastric pull-up.
Key exclusion criteria (4 listed)
- Severe heart failure and pulmonary dysfunction
- Severe renal and liver dysfunction
- Allergenic history
- Pregnancy
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 |
|---|---|---|
| Patients after esophagectomypostoperative endoscopic evaluation | Procedure or surgery | Patients after esophagectomy |
Primary outcome
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
Time frame: From 1 to 29 days after esophagectomy
Number of participants with the classification of gastric conduit ischemia by endoscopic findings
Time frame: From 1 to 15 days after esophagectomy
Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)
Time frame: From 1 to 29 days after esophagectomy
3 secondary outcomes
Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number
Time frame: From 1 to 29 days after esophagectomy
Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining
Time frame: From 1 to 29 days after esophagectomy
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
Time frame: From 1 to 29 days after esophagectomy
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 Oct 2016.
- Protocol information in University Hospital Medical Information Network (UMIN) （UMIN000019585）Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Esophageal Neoplasms
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Not yet recruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer
Esophageal Cancer
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Shinichiro Kobayashi study director
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms and Constriction, run by Nagasaki University at 1 site in Japan.
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 4 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 Oct 2016. 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 Japan. 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?
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification (time frame: From 1 to 29 days after esophagectomy). The study lists 3 primary outcomes in all. 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 Oct 2016.