Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial

Abstract

Background: Although radical gastrectomy with D2 lymph node dissection has become the standard surgical approach for locally advanced gastric cancer, patients still have a poor prognosis after operation. Previously, we proposed laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision [D2 + CME]) as an optimized surgical procedure for locally advanced gastric cancer. By dissection along the boundary of the mesogastrium, D2 + CME resected proximal segments of the dorsal mesogastrium completely with less blood loss, and it improved the short-term surgical outcome. However, the oncologic therapeutic effect of D2 + CME has not yet been confirmed.

Methods/design: A single-center, prospective, parallel-group, randomized controlled trial of laparoscopic distal gastrectomy with D2 + CME versus conventional D2 was conducted for patients with locally advanced gastric cancer at Tongji Hospital, Wuhan, China. In total, 336 patients who met the following eligibly criteria were included and were randomized to receive either the D2 + CME or D2 procedure: (1) pathologically proven adenocarcinoma; (2) 18 to 75 years old; cT2-4, N0-3, M0 at preoperative evaluation; (3) expected curative resection via laparoscopic distal gastrectomy; (4) no history of other cancer, chemotherapy, or radiotherapy; (5) no history of upper abdominal operation; and (6) perioperative American Society of Anesthesiologists class I, II, or III. The primary endpoint is 3 years of disease-free survival. The secondary endpoints are overall survival, recurrence pattern, mortality, morbidity, postoperative recovery course, and other parameters.

Discussion: Previous studies have demonstrated the safety and feasibility of D2 + CME for locally advanced gastric cancer; however, there is still a lack of evidence to support its therapeutic effect. Thus, we performed this randomized trial to investigate whether D2 + CME can improve oncologic outcomes of patients with locally advanced gastric cancer. The findings from this trial may potentially optimize the surgical procedure and may improve the prognosis of patients with locally advanced gastric cancer.

Trial registration: ClinicalTrials.gov, NCT01978444 . Registered on October 31, 2013.

Keywords: Complete mesogastrium excision; D2 lymphadenectomy; Gastric cancer; Laparoscopic distal gastrectomy; Randomized controlled trial.

Conflict of interest statement

Approval from Tongji Hospital Ethics Committee (TJ-C20130811) was received in August 2013. All patients signed an informed consent document before entering the study. Consent was taken by the consultant or designated team member and was preserved by the data collection group.

Written informed consent was obtained from the patients for publication of their individual details and accompanying images in this paper. The consent form is held by the authors’ institution and is available for review by the Editor-in-Chief of this journal.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Study flow diagram. AGC Advanced gastric cancer, D2 Gastrectomy with D2 lymphadenectomy, D2 + CME D2 lymphadenectomy plus complete mesogastrium excision, LADG Laparoscopy-assisted distal gastrectomy, XELOX Chemotherapy regimen consisting of capecitabine combined with oxaliplatin

Fig. 2

Gastrectomy and lymph node dissection in the conventional D2 procedure. The proximal margin of gastrectomy should achieve at least 3 cm for T2 or deeper tumors with an expansive growth pattern or 5 cm for those with an infiltrative growth pattern. The lymphadenectomy should include 1, 3, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, and 12a groups of lymph nodes [3]

Fig. 3

a Diagram of resected mesogastrium (yellow) during D2 + CME. b Intraoperative photographs show the standard procedures of mesenteric excision: (1) expose the mesogastrium clearly, (2) separate the mesentery from the mesenteric bed, (3) dissect along with the root of the mesentery, and (4) ligation should reach the root of the blood vessels. c Pictures of each mesogastrium were photographed under laparoscopy before (left) and after dissection (right) during D2 + CME. LGEM Left gastroepiploic mesentery, RGEM Right gastroepiploic mesentery, LGM Left gastric mesentery, RGM Right gastric mesentery, PGM Postgastric mesentery. Black arrow = mesogastrium [14]l

Fig. 4

Schedule of enrollments, interventions, and assessments