D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429841
• Other study ID #: 302764
• Status: Completed
• Start date: January 2010
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 2020
• Est. primary completion date: January 2016
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Radical gastrectomy with D1 lymphadenectomy

• Radical gastrectomy with D2 lymphadenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. Epub 2004 Apr 13. — View Citation

Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity rate	Frequency of early postoperative complications	30 days after surgery
Primary	Operative mortality rate	Frequency of early postoperative mortality	30 days after surgery
Secondary	5 years Recurrence rate	Frequency of tumor recurrence within 5 years after curative surgery	5 years after surgery
Secondary	5 years Cancer specific mortality rate	Frequency of Cancer specific mortality within 5 years after curative surgery	5 years after surgery
Secondary	5 years Disease free survival rate	Percentage of patients survived for 5 years after surgery without tumor recurrence	5 years after surgery
Secondary	5 years Overall survival rate	Percentage of patients survived for 5 years after surgery with/without tumor recurrence	5 years after surgery