An interventional study of Gastro-entero anastomosis only and Gastric partitioning Plus Gastro-entero anastomosis in Gastric Cancer, sponsored by Instituto do Cancer do Estado de São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Instituto do Cancer do Estado de São Paulo · Not applicable, Interventional, and Treatment
The incidence of unresectable and obstructive gastric cancer patients ranges in the literature from 5 to 30 % . In such cases, gastro-entero anastomosis is traditionally performed and can improve the quality of life by relieving the symptoms of impaired oral intake without having a high surgical risk. Unfortunately, up to 25% of these patients may develop impaired gastric emptying syndrome. Gastric partitioning was originally described by Devine in 1925 as a method of antral exclusion and complete division of the stomach accompanied by a gastro-entero anastomosis in the proximal gastric pouch for the management of difficult duodenal ulcers. This procedure has been modified along the years and was adopted for the palliative treatment of gastric cancer. The advantages of the partitioning includes: better gastric emptying, avoidance of direct tumor invasion of the gastro-entero anastomosis, less contact between the ingested food and the tumor with less blood lost and improved survival. Retrospective not randomized studies have been published demonstrating the effectiveness of the procedure.
The first group (Group A) will be considered the control group in which patients will undergo gastro-entero anastomosis. The anastomosis will be pre-colic, along the posterior wall of the stomach with the length of at least 5 cm. The first jejunal loop approximately 40 cm from the angle of Treitz will be used. The anastomosis can be performed manually or with staplers.
The second group (group B) will be considered the intervention group in which patients will undergo gastric partitioning plus gastro-entero anastomosis. The gastric partitioning is done 5 cm proximal to the lesion along the greater curvature towards the lesser curvature above the incisura using linear cutting stapler. The partitioning is performed horizontally and preserve a narrow tunnel along the lesser curvature that is calibrated with a orogastric tube gauge 32. Subsequently, a pre-colic gastro-entero anastomosis is performed in the proximal gastric chamber created by the partitioning. The anastomosis is done along the posterior wall, with at least 5 cm of length using the first jejunal loop approximately 40 cm from the angle of Treitz. The anastomosis can be performed manually or with staplers.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 52 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
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Exclusion Criteria:
Gastro-entero anastomosis only
Procedure: Gastro-entero anastomosis only
Gastric partitioning Plus Gastro-entero anastomosis
Procedure: Gastric partitioning Plus Gastro-entero anastomosis
Gastro-entero anastomosis only
Gastric partitioning Plus Gastro-entero anastomosis
Change from baseline Gastric Outlet Obstruction Score System - GOOSS
Gastric Obstruction measured by the gastric outlet obstruction scoring system (GOOSS). From baseline, participants will be followed every 2 months for the duration of survival, an expected average of less than 6 months
Time frame: 6 months
Overall survival
From baseline, participants will be followed every 2 months for the duration of survival, an expected average of less than 6 months
Time frame: 6 months
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Instituto do Cancer do Estado de São Paulo