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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gastro-entero anastomosis only
Gastric partitioning Plus Gastro-entero anastomosis
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Câncer do Estado de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: A

Experimental: B

Arm Description

Gastro-entero anastomosis only

Gastric partitioning Plus Gastro-entero anastomosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2014
Last Updated
December 17, 2021
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02064803
Brief Title
Gastric Partitioning Procedure for the Treatment of Unresectable and Obstructive Distal Gastric Cancer
Official Title
Randomized Clinical Trial Comparing Gastric Partitioning Plus Gastro-entero Anastomosis Versus Gastro-entero Anastomosis Only in Patients With Unresectable and Obstructive Distal Gastric Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group: A
Arm Type
Active Comparator
Arm Description
Gastro-entero anastomosis only
Arm Title
Experimental: B
Arm Type
Experimental
Arm Description
Gastric partitioning Plus Gastro-entero anastomosis
Intervention Type
Procedure
Intervention Name(s)
Gastro-entero anastomosis only
Intervention Description
Gastro-entero anastomosis only
Intervention Type
Procedure
Intervention Name(s)
Gastric partitioning Plus Gastro-entero anastomosis
Intervention Description
Gastric partitioning Plus Gastro-entero anastomosis
Primary Outcome Measure Information:
Title
Change from baseline Gastric Outlet Obstruction Score System - GOOSS
Description
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
Secondary Outcome Measure Information:
Title
Overall survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus K. Ramos, MD
Organizational Affiliation
Instituto do Câncer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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