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

NCT02546687 | Unknown DMC

• 1 other identifier: 0251-15-RMC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Esophagectomy

Keywords

Anastomotic Leak; Esophagectomy Gastric Pull-up

Outcome Measures

Primary Outcomes (5)

• 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.

  3 months

• The Clavien-Dindo Classification of Surgical Complications

  Ann of Surg 2009;250: 187-196

  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.

  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.)

  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.

  3 months

Study Arms (1)

Canidate for elective esophagectomy

Venous blood sampling from gastric tube during elective esophagectomy

Other: Venous blood sampling

Interventions

Venous blood sampling OTHER

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.

Canidate for elective esophagectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.

You may not qualify if:

• None.

Sponsors & Collaborators

• Rabin Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood gas mesurment

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 9, 2015
• First Posted: September 11, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 11, 2015

Record last verified: 2015-09