## Protocol Section
### Identification Module
**NCT ID:** NCT04599179

**Brief Title:** SEMS and Gastroenterostomy

**Official Title:** Stage IV Gastric Cancer: Patient's Quality of Life (QoL) After Surgical or Endoscopic Palliative Treatment.

#### Organization Study ID Info
**ID:** 14102020
#### Organization
**Class:** OTHER
**Full Name:** University of Roma La Sapienza
### Status Module
#### Completion Date
**Date:** 2020-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-22

**Type:** ACTUAL

**Last Update Submit Date:** 2020-10-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01-01

**Type:** ACTUAL

**Status Verified Date:** 2020-10

#### Study First Post Date
**Date:** 2020-10-22
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-16
**Study First Submit QC Date:** 2020-10-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Roma La Sapienza

#### Responsible Party

**Investigator Affiliation:** University of Roma La Sapienza

**Investigator Full Name:** ENRICO FIORI

**Investigator Title:** Professor of Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Stage IV Gastric Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: self-expandable metal stent

**Label:** Group 1

#### Arm Group 2

**Description:** Patients underwent to stomach-partitioning gastrojejunostomy

**Label:** Group 2

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

**Description:** self-expandable metal stent endoscopic positioning

**Name:** self-expandable metal stent

**Other Names:**

- stomach-partitioning gastrojejunostomy (SPGJ)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Quality of life (QoL) after endoscopic or surgical treatment

**Time Frame:** 6-12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria are age less than 85 years, pre-treatment histological diagnosis of gastric adenocarcinoma, computed tomographic (CT), adjuvant-neoadjuvant chemotherapy regimen, symptoms of GOOS (symptoms of GOOS include: regular, frequent feeling of bloating or fullness; feeling full after eating less food; nausea and vomiting of undigested food, especially right after eating, abdominal pain) lumen reduction ranging between 70% and 99% at gastroscopy.

Criteria for exclusion are a white blood cells count less than 4,000/L, a platelet count less than 70,000/L, patients with renal failure (i.e. albumin to creatinine ratio \> 30 mg/mmol and estimated glomerular filtration rate \< 30-44 mL/min/1.73m2), patients with major alterations of liver function tests (i.e. total bilirubin \> 25.6 μmol/L, AST \> 5 U/L, ALT \>5 U/L, PT-INR \> 1.5).

-

**Maximum Age:** 85 Years

**Minimum Age:** 30 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All patients presenting with stage IV antropyloric gastric cancer at our Institution are enrolled

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Roma

**Country:** Italy

**Facility:** Sapienza University

**State:** Lazio

**Zip:** 00161

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
