Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gastric partitioning Plus Gastro-entero anastomosis | Procedure | — | UNRESOLVED |
| Gastro-entero anastomosis only | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group: A
- description
- Gastro-entero anastomosis only
- interventionNames
- Procedure: Gastro-entero anastomosis only
- type
- EXPERIMENTAL
- label
- Experimental: B
- description
- Gastric partitioning Plus Gastro-entero anastomosis
- interventionNames
- Procedure: Gastric partitioning Plus Gastro-entero anastomosis
Primary outcomes (1)
- measure
- Change from baseline Gastric Outlet Obstruction Score System - GOOSS
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available