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

NCT ID: NCT02064803

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group: A

Gastro-entero anastomosis only

Group Type ACTIVE_COMPARATOR

Gastro-entero anastomosis only

Intervention Type PROCEDURE

Gastro-entero anastomosis only

Experimental: B

Gastric partitioning Plus Gastro-entero anastomosis

Group Type EXPERIMENTAL

Gastric partitioning Plus Gastro-entero anastomosis

Intervention Type PROCEDURE

Gastric partitioning Plus Gastro-entero anastomosis

Interventions

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Gastro-entero anastomosis only

Gastro-entero anastomosis only

Intervention Type PROCEDURE

Gastric partitioning Plus Gastro-entero anastomosis

Gastric partitioning Plus Gastro-entero anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus K. Ramos, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Câncer do Estado de São Paulo

Locations

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Instituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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NP382/13

Identifier Type: -

Identifier Source: org_study_id