SEMS and Gastroenterostomy

NCT04599179 | Completed

• 1 other identifier: 14102020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

More than 20% of patients with gastric cancer have at presentation a stage IV disease. Advanced adenocarcinoma of the antro-pyloric region often determines a condition of gastric outlet obstruction syndrome (GOOS), which requires a rapid resolution for the severe consequences that will occur if the obstruction is not resolved. GOOS causes malnutrition, fluid and electrolyte imbalances that are difficult to control. Laparoscopic or open gastroenterostomy has been proposed as the treatment of choice in patients with advanced unresectable distal stomach tumor presenting with symptoms of GOOS. Noticeably, laparoscopic gastroenterostomy might be difficult to be performed in a hostile abdomen because of the involvement of the root of the mesentery, infiltration of the surrounding structures and peritoneal carcinosis. Furthermore, laparoscopic or open gastroenterostomy provides suboptimal palliation, because it is associated with postoperative complications ranging from 15% to 50% related to a delayed gastric emptying and a protract postoperative hospital stay. These results negatively affect the quality of life (QoL), and therefore, the efficacy of gastroenterostomy for palliation has been questioned. In 1997, Kaminishi et al. introduced a technique of stomach-partitioning gastrojejunostomy (SPGJ), which divides the lower part of the stomach and connects the jejunum to the proximal part of the stomach while maintaining a tunnel that is 2 to 3 cm in diameter along the lesser curvature. This technique theoretically provides some benefits: endoscopic evaluation of the tumor response to adjuvant chemotherapy and the possibility of repeated endoscopic local treatment on the tumor, prevention of ingested food retention in the distal part of the stomach thus facilitating gastric emptying and improving patient's QoL. A current alternative to laparoscopic or open surgical approach to an advanced gastric tumor is the positioning of a self-expandable metal stent (SEMS) which offers many potential advantages: the avoidance of general anaesthesia for a laparoscopic or open approach, a shorter hospital stay and a minor patient postoperative discomfort. We want to perform a prospective longitudinal cohort trial, comparing the QoL of patients affected with stage IV antropyloric stomach cancer and symptoms of GOOS who underwent endoscopic placement of a SEMS or after open SPGJ.

Conditions

Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL) after endoscopic or surgical treatment

  6-12 months

Study Arms (2)

Group 1

Patients underwent placement of a self-expandable metal stent (SEMS)

Device: self-expandable metal stent

Group 2

Patients underwent to stomach-partitioning gastrojejunostomy

Interventions

self-expandable metal stent DEVICE

self-expandable metal stent endoscopic positioning

Also known as: stomach-partitioning gastrojejunostomy (SPGJ)

Group 1

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with stage IV antropyloric gastric cancer at our Institution are enrolled

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University

Rome, Lazio, 00161, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2010
• Primary Completion: January 1, 2020
• Study Completion: September 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

IT (1)