NCT02064803

Gastric Partitioning Procedure for the Treatment of Unresectable and Obstructive Distal Gastric Cancer

Randomized Clinical Trial Comparing Gastric Partitioning Plus Gastro-entero Anastomosis Versus Gastro-entero Anastomosis Only in Patients With Unresectable and Obstructive Distal Gastric Cancer.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Gastro-entero anastomosis only	Gastro-entero anastomosis only
PROCEDURE	Gastric partitioning Plus Gastro-entero anastomosis	Gastric partitioning Plus Gastro-entero anastomosis

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-12-01
• Completion: 2020-07-01
• First posted: 2014-02-17
• Last updated: 2021-12-21

Locations

1 site across 1 country: Brazil