- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599179
SEMS and Gastroenterostomy
Stage IV Gastric Cancer: Patient's Quality of Life (QoL) After Surgical or Endoscopic Palliative Treatment.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lazio
-
Roma, Lazio, Italy, 00161
- Sapienza University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients underwent placement of a self-expandable metal stent (SEMS)
|
self-expandable metal stent endoscopic positioning
Other Names:
|
Group 2
Patients underwent to stomach-partitioning gastrojejunostomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (QoL) after endoscopic or surgical treatment
Time Frame: 6-12 months
|
6-12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14102020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IV Gastric Cancer
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 and other conditionsUnited States
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
University of ChicagoNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Gastric Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Malignant Gastrointestinal Neoplasm | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Gallbladder Carcinoma | Stage IV Gallbladder Cancer | Stage IV Gastric Cancer | Stage IIIA Gallbladder Cancer | Stage... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingClinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastric Adenocarcinoma | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8 | Clinical... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer | Stage IV Gastric Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Recurrent Gastric Cancer | Stage III Colon Cancer | Stage III Gastric Cancer | Stage III Rectal...United States
-
National Cancer Institute (NCI)CompletedStage IV Gastric Cancer | Stage III Gastric CancerUnited States
-
M.D. Anderson Cancer CenterRecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Oligometastasis | Stage IV Esophageal Cancer AJCC v7 | Stage IV Gastric Cancer AJCC v7 | Stage IV Esophageal Adenocarcinoma AJCC v7United States
Clinical Trials on self-expandable metal stent
-
Yonsei UniversityUnknownColorectal CancerKorea, Republic of
-
Seoul National University HospitalRecruitingMalignant Biliary ObstructionKorea, Republic of
-
Johns Hopkins UniversityBoston Scientific CorporationRecruitingGastric Outlet ObstructionUnited States, India, France, Canada, Ecuador, Spain
-
Ajou University School of MedicineCompletedMalignant Distal Biliary StrictureKorea, Republic of
-
Erasmus Medical CenterNot yet recruiting
-
Helsinki University Central HospitalRecruitingPancreatic Cancer | Pancreatic Duct StrictureFinland
-
Sahlgrenska University Hospital, SwedenCompletedIntestinal Strictures Related to Crohn´s Disease
-
Radboud University Medical CenterErasmus Medical CenterTerminatedOesophageal Cancer | Esophageal Stent StenosisNetherlands
-
AdventHealthCompletedPancreatic Collection | Infected Pancreatic Necrosis | Acute Pancreatic Fluid Collection | Pancreatic and Peripancreatic Necrosis | Symptomatic Pancreatic NecrosisUnited States
-
Mayo ClinicTenwek Hospital, Bomet, KenyaCompleted