Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: D2 lymphadenectomy; Procedure: D1 lymphadenectomy

• Registration Number: NCT04340440
• Lead Sponsor: University of Alexandria

Brief Summary

Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Detailed Description

80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2017-09
• Study Completion: 2020-02
• Status Verified: 2020-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Histologically confirmed gastric carcinoma
• Potentially operable gastric carcinoma without evidence of distant metastasis

Exclusion Criteria

• Complicated gastric cancer (obstructed or perforated)
• Locally irresectable tumor
• Previous or coexisting cancer
• Prior gastric surgery or neoadjuvant chemotherapy
• Contraindication for major surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D2 lymphadenectomy	D2 lymphadenectomy	Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy
D1 lymphadenectomy	D1 lymphadenectomy	Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity rate	30 days after surgery	Frequency of early postoperative complications
Operative mortality rate	Within 30 days after surgery	Frequency of early postoperative mortality

Secondary Outcome Measures

Name	Time	Method
2 years Disease free survival rate	2 years after surgery	Percentage of patients survived for 2 years without tumor recurrence
2 years Cancer specific mortality rate	2 years after surgery	Frequency of patients died because of gastric cancer within 2 years after curative surgery
2 years Recurrence rate	2 years after surgery	Frequency of tumor recurrence within 2 years after curative surgery
2 years Overall survival rate	2 years after surgery	Percentage of patients survived for 2 years with/without tumor recurrence