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D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04429841
Enrollment
148
Registered
2020-06-12
Start date
2010-01-31
Completion date
2020-06-30
Last updated
2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Operable Gastric Cancer, D2 Gastrectomy, D1 Gastrectomy, Operative Mortality & Morbidity, Oncological Outcomes

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURERadical gastrectomy with D1 lymphadenectomy

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative morbidity rate30 days after surgeryFrequency of early postoperative complications
Operative mortality rate30 days after surgeryFrequency of early postoperative mortality

Secondary

MeasureTime frameDescription
5 years Recurrence rate5 years after surgeryFrequency of tumor recurrence within 5 years after curative surgery
5 years Cancer specific mortality rate5 years after surgeryFrequency of Cancer specific mortality within 5 years after curative surgery
5 years Disease free survival rate5 years after surgeryPercentage of patients survived for 5 years after surgery without tumor recurrence
5 years Overall survival rate5 years after surgeryPercentage of patients survived for 5 years after surgery with/without tumor recurrence

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026