Clinical trial NCT04340440: Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma
Official title: Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Operable gastric cancer
D2 vs D1 lymphadenectomy
Surgical and Oncologic outcomes
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morbidity rate
timeFrame: 30 days after surgery
measure: Operative mortality rate
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: 2 years Recurrence rate
timeFrame: 2 years after surgery
measure: 2 years Cancer specific mortality rate
timeFrame: 2 years after surgery
measure: 2 years Disease free survival rate
timeFrame: 2 years after surgery
measure: 2 years Overall survival rate
timeFrame: 2 years after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.
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. doi: 10.1016/S1470-2045(06)70623-4.
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.