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

NCT02064803 | Completed

• 1 other identifier: NP382/13
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  6 months

Study Arms (2)

Control group: A

ACTIVE COMPARATOR

Gastro-entero anastomosis only

Procedure: Gastro-entero anastomosis only

Experimental: B

EXPERIMENTAL

Gastric partitioning Plus Gastro-entero anastomosis

Procedure: Gastric partitioning Plus Gastro-entero anastomosis

Interventions

Gastro-entero anastomosis only PROCEDURE

Gastro-entero anastomosis only

Control group: A

Gastric partitioning Plus Gastro-entero anastomosis PROCEDURE

Gastric partitioning Plus Gastro-entero anastomosis

Experimental: B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Marcus K. Ramos, MD

  Instituto do Câncer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 17, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2020
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

BR (1)