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

BackgroundAlthough 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/designA 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.DiscussionPrevious 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 registrationClinicalTrials.gov, NCT01978444. Registered on October 31, 2013.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2790-5) contains supplementary material, which is available to authorized users.

Surgical and oncological outcomes of laparoscopic right hemicolectomy (D3 + CME) for colon cancer: A prospective single-center cohort study

“…Based on the MBS model, we proposed an anatomical model named the proximal segment of dorsal mesogastrium (PSDM) in gastric cancer research [ 37 ], and subsequently proposed the MBS-based surgery named D2 + CME [ 38 ]; we then demonstrated the advantages of that procedure in surgical and oncological outcomes [ 36 , 39 – 41 ]. The study D3 + CME for colon cancer here is amazingly consistent with D2 + CME for gastric cancer.…”

Uncovering the Impact of Lymphadenectomy in Advanced Gastric Cancer: A Comprehensive Review

“…D2 lymphadenectomy involves the removal of an extended set of regional lymph nodes, ensuring a more comprehensive excision. This approach provides several benefits for patients with advanced gastric cancer [ 76 , 77 ]. Firstly, D2 lymphadenectomy increases the likelihood of detecting and removing metastatic lymph nodes, improving staging accuracy and subsequent treatment decisions.…”

Totally laparoscopic total gastrectomy using the "enjoyable space" approach coupled with self-pulling and latter transection reconstruction versus laparoscopic-assisted total gastrectomy for upper gastric cancer: short-term outcomes.

“…Intraoperative oncological safety is a critical assessment of TLTG using SPLT for the treatment of gastric cancer. Since the perigastric mesogastrium plays an important role in “metastasis V” and contains the supporting vascular, nerve and lymphatic systems of the posterior wall of the stomach, radical resection of gastric cancer is insufficient if only the related LNs are dissected [ 24 , 25 ]. CME should be conducted to remove the primary lesion and the adjacent soft tissue to achieve oncological en bloc resection.…”