EsophagectomyNCT02546687
Prediction of Anastomotic Leak/Stricture After Esophagectomy With Gastric Pull-up by Venous Blood Gas
An observational study of Esophagectomy, run by Rabin Medical Center.
Trial summary
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy
- What is being tested?
- Venous blood sampling
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Who may be able to join
- Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Who cannot join
- None.
About this study
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
Read more
The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures.
After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
This is prospective study. Anticipated cohort of 50 patients
Read the detailed description
Prediction of Anastomotic Leak/Stricture after Esophagectomy with Gastric Pull-up by Venous Blood Gas.
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
There are a lot of methods for intraoperative assessment of gastric tube perfusion. This methods include basic (as color, temperature of tube) and advanced assessment as optical fiber spectroscopy, visible light spectroscopy, the combination of a laser Doppler flowmeter and spectrophotometer, a laser Doppler imager, partial tissue oxygen pressure with a Clark-type polar graphic oxygen electrode, continuous measurement of mucosal PCO2 using recirculation gas analysis with a TONOCAP device together with mean arterial pressure measurement, and cardiac output and systemic vascular resistance by pulse contour analysis laser-assisted fluorescent-dye angiography (1-5).
All this methods are comparative complicated and do not promise good assessment results.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures.
After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
Objectives The aims of this study is to compare the changes in venous blood gas in gastric tube together with systemic venous blood before construction of gastric tube and just before creation of anastomosis . After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
Study Design This is prospective study. Anticipated cohort of 50 patients The investigators are planning to take 1-2 cc of venous blood from proximal part of stomach before gastric tube creation and in the same time the investigators will take same amount of venous blood from peripheral vein. This blood will be analyzed in the "ABL800 FLEX blood gas analyzer" (Radiometer Copenhagen) as a routine blood analyses that making by anesthesiologist during the operation. This blood sampling the investigators will make again after 15-30 minutes from the same area in proximal stomach (after creation of gastric tube) and peripheral vein just before anastomosis creation. Important that because of technical needs (regardless our study) this stomach area from where the investigators are going to get blood for analyses will be removed immediately after anastomosis creation. So there is no danger for future injury or tissue changes for the patient due to needle stubbing for blood analyses.
Every patient will undergo routine follow up in the surgical department for minimum 7-10 hospitalization days with describing signs of anastomotic leak. Patients will continue routine follow up in our outpatient clinic (as every patient after such kind of surgery) two weeks, 6 weeks and 3 months after discharge from surgical department with evaluation of anastomotic stricture signs.
Participants. Inclusion criteria Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Data collection and statistical analysis. Data will be collected about patients demographic data, comorbidities, kind of pathology, neoadjuvant treatment (for cancer patients), time of surgery, patient hemodynamic state during surgery. The investigators will collect blood results especially measure of O2, pH, CO2, lactate. After surgery the investigators will describe and collect clinical and radiological signs of anastomotic leak and stricture.
Statistical analysis. Logistic regression and ROC (receiver operating characteristic) will be used to assess relationship between the blood gas changes and rate of anastomotic leak and stricture.
- Conditions
- Esophagectomy
- Being tested
- Venous blood sampling
- Keywords
- Anastomotic Leak, Esophagectomy Gastric Pull-up
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood samplingOther
The investigators will take 1-2 cc of venous blood from proximal part of stomach before gastric tube creation and in the same time the investigators will take same amount of venous blood from peripheral vein. This blood will be analyzed in the "ABL800 FLEX blood gas analyzer" as a routine blood analyses that making by anesthesiologist during the operation. This blood sampling the investigators will make again after 15-30 minutes from the same area in proximal stomach (after creation of gastric tube) and peripheral vein just before anastomosis creation. The investigators will measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
| Study group | Role | What they receive |
|---|---|---|
| Canidate for elective esophagectomy | Venous blood sampling from gastric tube during elective esophagectomy Receives: Other: Venous blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Criteria for defining a surgical site infection (SSI)
Data from: Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection. In: Infection Control and Hospital Epidemiology, CDC 1999; 20:247.
Measured: 3 months
The Clavien-Dindo Classification of Surgical Complications
Ann of Surg 2009;250: 187-196
Measured: 3 months
Definition and measurement of anastomotic leak
Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Bruce J1, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Br J Surg. 2001 Sep;88(9):1157-68.
Measured: 3 months
Assessment of anastomotic stricture severity
Assessment of anastomotic stricture severity for minimal, mild, moderate, or severe by dysphagia assessment with standardized dysphagia severity score (Endoscopic and symptomatic assessment of anastomotic strictures following esophagectomy and cervical esophagogastrostomy. Williams VA1, Watson TJ, Zhovtis S, Gellersen O, Raymond D, Jones C, Peters JH. Surg Endosc. 2008 Jun;22(6):1470-6. Epub 2007 Nov 20.)
Measured: 3 months
Assessment of anastomotic stricture severity
Assessment of anastomotic stricture severity by size for minimal (12 mm), mild (9-12 mm), moderate (5-8 mm), or severe (<5 mm) using endoscopy or Barium esophagram.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veacheslav Zilbermints, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546687
- Sponsor's protocol ID
- 0251-15-RMC
- Status last verified
- Sep 2015
- First submitted
- 9 Aug 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Anastomotic Leak/Stricture After Esophagectomy With Gastric Pull-up by Venous Blood Gas
- ClinicalTrials.gov ID
- NCT02546687
- Acronym / sponsor ID
- 0251-15-RMC
- Conditions
- Esophagectomy
- Keywords
- Anastomotic Leak, Esophagectomy Gastric Pull-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Sep 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.
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures.
After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
This is prospective study. Anticipated cohort of 50 patients
Detailed description
Prediction of Anastomotic Leak/Stricture after Esophagectomy with Gastric Pull-up by Venous Blood Gas.
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
There are a lot of methods for intraoperative assessment of gastric tube perfusion. This methods include basic (as color, temperature of tube) and advanced assessment as optical fiber spectroscopy, visible light spectroscopy, the combination of a laser Doppler flowmeter and spectrophotometer, a laser Doppler imager, partial tissue oxygen pressure with a Clark-type polar graphic oxygen electrode, continuous measurement of mucosal PCO2 using recirculation gas analysis with a TONOCAP device together with mean arterial pressure measurement, and cardiac output and systemic vascular resistance by pulse contour analysis laser-assisted fluorescent-dye angiography (1-5).
All this methods are comparative complicated and do not promise good assessment results.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures.
After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
Objectives The aims of this study is to compare the changes in venous blood gas in gastric tube together with systemic venous blood before construction of gastric tube and just before creation of anastomosis . After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
Study Design This is prospective study. Anticipated cohort of 50 patients The investigators are planning to take 1-2 cc of venous blood from proximal part of stomach before gastric tube creation and in the same time the investigators will take same amount of venous blood from peripheral vein. This blood will be analyzed in the "ABL800 FLEX blood gas analyzer" (Radiometer Copenhagen) as a routine blood analyses that making by anesthesiologist during the operation. This blood sampling the investigators will make again after 15-30 minutes from the same area in proximal stomach (after creation of gastric tube) and peripheral vein just before anastomosis creation. Important that because of technical needs (regardless our study) this stomach area from where the investigators are going to get blood for analyses will be removed immediately after anastomosis creation. So there is no danger for future injury or tissue changes for the patient due to needle stubbing for blood analyses.
Every patient will undergo routine follow up in the surgical department for minimum 7-10 hospitalization days with describing signs of anastomotic leak. Patients will continue routine follow up in our outpatient clinic (as every patient after such kind of surgery) two weeks, 6 weeks and 3 months after discharge from surgical department with evaluation of anastomotic stricture signs.
Participants. Inclusion criteria Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Data collection and statistical analysis. Data will be collected about patients demographic data, comorbidities, kind of pathology, neoadjuvant treatment (for cancer patients), time of surgery, patient hemodynamic state during surgery. The investigators will collect blood results especially measure of O2, pH, CO2, lactate. After surgery the investigators will describe and collect clinical and radiological signs of anastomotic leak and stricture.
Statistical analysis. Logistic regression and ROC (receiver operating characteristic) will be used to assess relationship between the blood gas changes and rate of anastomotic leak and stricture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canidate for elective esophagectomy | – | Other: Venous blood samplingVenous blood sampling from gastric tube during elective esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Key inclusion criteria (1 listed)
- Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Venous blood samplingThe investigators will take 1-2 cc of venous blood from proximal part of stomach before gastric tube creation and in the same time the investigators will take same amount of venous blood from peripheral vein. This blood will be analyzed in the "ABL800 FLEX blood gas analyzer" as a routine blood analyses that making by anesthesiologist during the operation. This blood sampling the investigators will make again after 15-30 minutes from the same area in proximal stomach (after creation of gastric tube) and peripheral vein just before anastomosis creation. The investigators will measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood. | Other | Canidate for elective esophagectomy |
Primary outcome
Criteria for defining a surgical site infection (SSI)
Time frame: 3 months
Data from: Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection. In: Infection Control and Hospital Epidemiology, CDC 1999; 20:247.
The Clavien-Dindo Classification of Surgical Complications
Time frame: 3 months
Ann of Surg 2009;250: 187-196
Definition and measurement of anastomotic leak
Time frame: 3 months
Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Bruce J1, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Br J Surg. 2001 Sep;88(9):1157-68.
Assessment of anastomotic stricture severity
Time frame: 3 months
Assessment of anastomotic stricture severity for minimal, mild, moderate, or severe by dysphagia assessment with standardized dysphagia severity score (Endoscopic and symptomatic assessment of anastomotic strictures following esophagectomy and cervical esophagogastrostomy. Williams VA1, Watson TJ, Zhovtis S, Gellersen O, Raymond D, Jones C, Peters JH. Surg Endosc. 2008 Jun;22(6):1470-6. Epub 2007 Nov 20.)
Assessment of anastomotic stricture severity
Time frame: 3 months
Assessment of anastomotic stricture severity by size for minimal (12 mm), mild (9-12 mm), moderate (5-8 mm), or severe (<5 mm) using endoscopy or Barium esophagram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
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 Rabin Medical 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: status not confirmed, as of the sponsor's last update on 11 Sep 2015. 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?
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?
Criteria for defining a surgical site infection (SSI) (time frame: 3 months). The study lists 5 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 11 Sep 2015.