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Status unknownNCT02546687Updated Sep 11, 2015

Prediction of Anastomotic Leak/Stricture After Esophagectomy With Gastric Pull-up by Venous Blood Gas

An observational study in Esophagectomy, sponsored by Rabin Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-11.

Sponsored by Rabin Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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. 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

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.

02

Conditions studied

  • Esophagectomy

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Keywords

  • Anastomotic Leak
  • Esophagectomy Gastric Pull-up
03

In context

Anastomotic Leak

218 studies on the registry are indexed under Anastomotic Leak; 62 are open to participants now.

This study's planned enrollment of 50 is below the median of 194 across 114 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

Exclusion criteria

Exclusion Criteria:

  • None.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Canidate for elective esophagectomy

    Venous blood sampling from gastric tube during elective esophagectomy

    Other: Venous blood sampling

Interventions

  • OtherVenous blood sampling

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. The Clavien-Dindo Classification of Surgical Complications

    Ann of Surg 2009;250: 187-196

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.)

    Time frame: 3 months

  5. 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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Aug 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2015
First posted
Sep 11, 2015
Start
Aug 2015
Primary completionEst.
Aug 2016
CompletionEst.
Dec 2016
Last update
Sep 11, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02546687
Responsible party
Veacheslav Zilbermints (MD, Rabin Medical Center) — Principal investigator
First posted
Sep 11, 2015
Start date
Aug 2015
Primary completion
Aug 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Sep 11, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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