Primary results of a phase III trial to evaluate bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).

Abstract

5 Background: The role of bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-bursectomy arm or bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-bursectomy 602, bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was performed on Sep 2016, with 54% (196/363) of the expected events observed. The 3y-survival were 86.0% (95%CI, 82.7 to 88.7) in non-bursectomy arm and 83.3% (95%CI, 79.6 to 86.3) in bursectomy arm. Hazard ratio for bursectomy was 1.075 (98.5%CI: 0.760 to 1.520) with predictive probability in favor of bursectomy at the final analysis of 12.7%. These results led to early study termination based on the recommendation of the Data and Safety Monitoring Committee. Operation time was longer (median 222 min vs 254 min) and blood loss was larger (230 ml vs 330 ml) in bursectomy arm; however, the incidence of patients received blood transfusion was not different between the arms (4.8% vs 4.5%). Although the incidence of pancreatic fistula was a bit higher in bursectomy arm (2.5% vs 4.8%), the incidence of Grade 3 or higher complications was not different between the arms (11.6% vs 13.3%). Five patients in non-bursectomy arm and one patient in bursectomy showed in-hospital death. Conclusions: Although bursectomy can be safely performed without increasing morbidity and mortality, bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.

Laparoscopic D2 plus complete mesogastrium excision using the "enjoyable space" approach versus conventional D2 total gastrectomy for local advanced gastric cancer: short-term outcomes.

“…In our study, the overall postoperative morbidity was 12.7%, which was consistent with that in the relevant literature [23][24][25][26][27]. Some similar studies on CME have suggested that bursectomy does not increase the risk of postoperative morbidity [23,28]. Accordingly, our data showed that although the postoperative complication rate in the D2 + CME group was slightly lower than that in the D2 group (9.5% (8/84) vs. 16.0% (13/81)), there was no significant difference between the two groups, suggesting that the "enjoyable space" approach was safe and did not increase the postoperative complication rate.…”

“…The assessment of postoperative complications is necessary for evaluating a novel technique. In our study, the overall postoperative morbidity was 12.7%, which was consistent with that in the relevant literature [23][24][25][26][27]. Some similar studies on CME have suggested that bursectomy does not increase the risk of postoperative morbidity [23,28].…”

Japanese gastric cancer treatment guidelines 2018 (5th edition)

“…Bursectomy for tumors penetrating the serosa of the posterior gastric wall had been performed with the aim of removing microscopic tumor deposits within the omental cavity. However, survival benefit of this procedure has been denied by a large-scale randomized trial (JCOG1001), not only for all patients registered but also for subsets with T4a tumors and tumors located in the posterior wall [8].…”

Universalization of the operative strategy by systematic mesogastric excision for stomach cancer with that for total mesorectal excision and complete mesocolic excision colorectal counterparts

“…Totally excising the mesogastrium should entail omento‐bursectomy, which was considered standard in Japan from 1950’ to prevent peritoneal metastasis. However, recent results of a phase III JCOG1001 trial revealed that omento‐bursectomy provides no benefit over omentectomy alone for patients with subserosal/serosal gastric cancer . The omentum has lymphatic pathways but contains no regional LN .…”