Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

University of Alexandria

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: D2 lymphadenectomy; Procedure: D1 lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04340440

0302764

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

D1 lymphadenectomy

Active Comparator group

Description:

Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy

Treatment:

Procedure: D1 lymphadenectomy

D2 lymphadenectomy

Active Comparator group

Description:

Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy

Treatment:

Procedure: D2 lymphadenectomy