Clinical trial NCT04429841: D2 Versus D1 Gastrectomy of Operable Gastric Cancer
Official title: Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Operable Gastric Cancer
D2 Gastrectomy
D1 Gastrectomy
Operative Mortality & Morbidity
Oncological Outcomes
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative morbidity rate
timeFrame: 30 days after surgery
measure: Operative mortality rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: 5 years Recurrence rate
timeFrame: 5 years after surgery
measure: 5 years Cancer specific mortality rate
timeFrame: 5 years after surgery
measure: 5 years Disease free survival rate
timeFrame: 5 years after surgery
measure: 5 years Overall survival rate
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Alexandria
country: Egypt
Study officials:
affiliation: Assistant Professor of Surgery
name: Mohamed Elmessiry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.