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
About this trial
This is an interventional treatment trial for Gastric Cancer
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
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
NCT ID
NCT02064803
First Posted
January 31, 2014
Last Updated
December 17, 2021
Sponsor
Instituto do Cancer do Estado de São Paulo
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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