Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

Gastric Cancer Clinical Trial

Official title:

Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340440
• Other study ID #: 0302764
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• D1 lymphadenectomy
Radical gastrectomy with D1 lymphadenectomy
• D2 lymphadenectomy
Radical gastrectomy with D2 lymphadenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

References & Publications (3)

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

Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J. Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol. 2006 Apr;7(4):309-15. — 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	Within 30 days after surgery
Secondary	2 years Recurrence rate	Frequency of tumor recurrence within 2 years after curative surgery	2 years after surgery
Secondary	2 years Cancer specific mortality rate	Frequency of patients died because of gastric cancer within 2 years after curative surgery	2 years after surgery
Secondary	2 years Disease free survival rate	Percentage of patients survived for 2 years without tumor recurrence	2 years after surgery
Secondary	2 years Overall survival rate	Percentage of patients survived for 2 years with/without tumor recurrence	2 years after surgery