Alexandria, Egypt
NCT Number: NCT04429841
D2 Versus D1 Gastrectomy of Operable Gastric Cancer
Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years
Exclusion criteria
- Complicated gastric cancer (obstructed or perforated)
- Irresectable or metastatic disease
- Previous or coexisting cancer
- Prior gastric surgery.
Treatment and study plan
Radical gastrectomy with D1 lymphadenectomy
ProcedureRadical gastrectomy with D2 lymphadenectomy
ProcedurePrimary outcomes
-
Postoperative morbidity rate
Time frame: 30 days after surgery
Frequency of early postoperative complications
-
Operative mortality rate
Time frame: 30 days after surgery
Frequency of early postoperative mortality
Secondary outcomes
-
5 years Recurrence rate
Time frame: 5 years after surgery
Frequency of tumor recurrence within 5 years after curative surgery
-
5 years Cancer specific mortality rate
Time frame: 5 years after surgery
Frequency of Cancer specific mortality within 5 years after curative surgery
-
5 years Disease free survival rate
Time frame: 5 years after surgery
Percentage of patients survived for 5 years after surgery without tumor recurrence
-
5 years Overall survival rate
Time frame: 5 years after surgery
Percentage of patients survived for 5 years after surgery with/without tumor recurrence
Sponsors and collaborators
Lead sponsor
Alexandria University
Other
Registry information
Official study title
Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer
Important dates
- Study start
- 2010
- Primary completion
- 2016
- Study completion
- 2020
- First posted
- Jun 12, 2020
- Registry last updated
- Jun 12, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Study of Oxaliplatin and Xeloda and Cetuximab as First Line Treatment for Metastatic or Unresectable Gastric or Gastroesophageal Junction Cancer
NCT00183898
Digestive System Diseases, Digestive System Neoplasms
Los Angeles, California, United States
View Trial DetailsNutrition Intervention Trials in Linxian Follow-up Study
NCT00342654
Digestive System Diseases, Digestive System Neoplasms
Beijing, China
View Trial DetailsA Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
NCT05396300
Colonic Diseases, Colorectal Cancer
Hangzhou, Zhejiang, China
View Trial DetailsSafety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
NCT05538195
Colon Cancer, Colonic Diseases
Henan, China
View Trial Details