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.

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Gastro-entero anastomosis only; Procedure: Gastric partitioning Plus Gastro-entero anastomosis

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with distal obstructive gastric tumors without indication of curative or palliative resection.
• Obstruction is defined as GOOSS (Gastric outlet obstruction score system) of 2 or less, associated with early vomiting and bloating if the patient try to keep the usual volume of food intake.
• Confirmation that obstruction is gastroduodenal by imaging and Upper Digestive Endoscopy ( EDA )
• Absence of other points of obstruction distal to the gastric tumor
• Histological diagnosis of cancer confirmed by biopsy
• Patients who has signed the informed consent form

Exclusion Criteria:

• Refusal to sign the informed consent form
• Tumors with indication of curative or palliative resection
• Proximal gastric tumors located above the incisura along the lesser curvature
• Tumors that invade the greater curvature above the middle third of the stomach
• Patients with low clinical performance - ECOG (Eastern Cooperative Oncology Group) 3 and 4.
• Obstruction located in the small intestine or colon
• Diffuse peritoneal carcinomatosis with peritoneal carcinomatosis index greater than 12

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group: A; Gastro-entero anastomosis only	Procedure: Gastro-entero anastomosis only; Gastro-entero anastomosis only
Experimental: Experimental: B; Gastric partitioning Plus Gastro-entero anastomosis	Procedure: Gastric partitioning Plus Gastro-entero anastomosis; Gastric partitioning Plus Gastro-entero anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From baseline, participants will be followed every 2 months for the duration of survival, an expected average of less than 6 months	6 months

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Marcus K. Ramos, MD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: NP382/13