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临床试验/NCT02546687
NCT02546687Unknown不适用

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

Rabin Medical Center0 个研究点目标入组 50 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
The Clavien-Dindo Classification of Surgical Complications

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

The Clavien-Dindo Classification of Surgical Complications

时间窗: 3 months

Ann of Surg 2009;250: 187-196

Definition and measurement of anastomotic leak

时间窗: 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

时间窗: 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.

Criteria for defining a surgical site infection (SSI)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Veacheslav Zilbermints

MD

Rabin Medical Center

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