EsophagectomyNCT04597398
Utility of the Evaluation of Blood Flow of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction
An observational study of Esophagectomy, run by Shizuoka Cancer Center.
Trial summary
Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagectomy
- What is being tested?
- Evaluation of blood flow with indocyanine green
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 30 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between January 2011 and June 2020, 50 patients underwent esophagectomy with pedicled jejunum reconstruction at our institute. The patients underwent subtotal esophagectomy via right thoracotomy with either an endoscopic or open procedure.
Who may be able to join
- patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020
Who cannot join
- patients who did not complete the esophagectomy
About this study
Official title: Utility of the Evaluation of Blood Flow With Indocyanine Green in Setting the Anastomosis Site of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction: A Case Series
Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique. Therefore, in the current study, we considered the utility of the evaluation of blood flow of the remnant esophagus with indocyanine green in setting the anastomosis site. We included 50 patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020. From June 2019, the blood flow of not only the pedicled jejunum, but also the remnant esophagus were evaluated in order to set the anastomosis site of the latter because the color was not definitive criteria for judging in surgery on the remnant esophagus. Usually, the second and third jejunal vessels are transected, and if the jejunal flap cannot reach to the anastomosis point, we actively transect the marginal vessels in order to stretch the jejunal flap. Microvascular anastomosis between the jejunal branches (the second) and the internal thoracic vessels is usually made, and the anastomosis site is set at the part of the esophagus that is well-dyed with indocyanine green. A total of 39 patients underwent the procedure prior to June 2019 ( Group A), and 11 patients underwent the procedure as of June 2019 (Group B). No significant difference was found in the patients' background, type of preoperative therapy, and presence or absence of ligation of marginal vessels and two-stage operation between the two groups. Group A had 16 cases of anastomosis leakage, while Group B only has one (P < 0.05). There were no cases of significant pedicled jejunum graft necrosis. Our findings demonstrate that the evaluation of the blood flow of the remnant esophagus during setting of the anastomosis site may decrease the rate of anastomosis.
- Conditions
- Esophagectomy
- Being tested
- Evaluation of blood flow with indocyanine green
- Keywords
- Esophageal reconstructive surgery, Remnant esophagus,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of blood flow with indocyanine greenDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A | A total of 39 patients underwent the procedure prior to June 2019 | |
| Group B | 11 patients underwent the procedure as of June 2019 Receives: Device: Evaluation of blood flow with indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomosis leakage
the rate of anastomosis leakage between remnant esophagus and pedicled jejunum
Measured: 1months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Apr 2012
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shizuoka Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenjiro Ishii, Shizuoka Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597398
- Sponsor's protocol ID
- ShizuokaCC
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Evaluation of Blood Flow With Indocyanine Green in Setting the Anastomosis Site of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction: A Case Series
- ClinicalTrials.gov ID
- NCT04597398
- Acronym / sponsor ID
- ShizuokaCC
- Conditions
- Esophagectomy
- Keywords
- Esophageal reconstructive surgery, Remnant esophagus,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shizuoka Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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.
Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique. Therefore, in the current study, we considered the utility of the evaluation of blood flow of the remnant esophagus with indocyanine green in setting the anastomosis site. We included 50 patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020. From June 2019, the blood flow of not only the pedicled jejunum, but also the remnant esophagus were evaluated in order to set the anastomosis site of the latter because the color was not definitive criteria for judging in surgery on the remnant esophagus. Usually, the second and third jejunal vessels are transected, and if the jejunal flap cannot reach to the anastomosis point, we actively transect the marginal vessels in order to stretch the jejunal flap. Microvascular anastomosis between the jejunal branches (the second) and the internal thoracic vessels is usually made, and the anastomosis site is set at the part of the esophagus that is well-dyed with indocyanine green. A total of 39 patients underwent the procedure prior to June 2019 ( Group A), and 11 patients underwent the procedure as of June 2019 (Group B). No significant difference was found in the patients' background, type of preoperative therapy, and presence or absence of ligation of marginal vessels and two-stage operation between the two groups. Group A had 16 cases of anastomosis leakage, while Group B only has one (P < 0.05). There were no cases of significant pedicled jejunum graft necrosis. Our findings demonstrate that the evaluation of the blood flow of the remnant esophagus during setting of the anastomosis site may decrease the rate of anastomosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –A total of 39 patients underwent the procedure prior to June 2019 |
| Group B | – | Device: Evaluation of blood flow with indocyanine green11 patients underwent the procedure as of June 2019 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between January 2011 and June 2020, 50 patients underwent esophagectomy with pedicled jejunum reconstruction at our institute. The patients underwent subtotal esophagectomy via right thoracotomy with either an endoscopic or open procedure.
Key inclusion criteria (1 listed)
- patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020
Key exclusion criteria (1 listed)
- patients who did not complete the esophagectomy
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 |
|---|---|---|
| Evaluation of blood flow with indocyanine green | Device | Group B |
Primary outcome
anastomosis leakage
Time frame: 1months after surgery
the rate of anastomosis leakage between remnant esophagus and pedicled jejunum
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 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Esophagectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 3
Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
Esophageal Cancer
RecruitingPhase 2
OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Anastomotic Leak Esophagus
Active, not recruitingObservational study
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Esophageal Cancer, Esophagus Cancer
RecruitingObservational study
Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
Oesophageal Cancer, Oesophageal Adenocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy, run by Shizuoka Cancer Center.
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 1 inclusion and 1 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
anastomosis leakage (time frame: 1months after surgery). 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 22 Oct 2020.