Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07, a randomized controlled trial.

BACKGROUNDS: Strong evidence is lacking as no confirmatory randomized controlled trials (RCTs) have compared the efficacy of totally laparoscopic distal gastrectomy (TLDG) with laparoscopy-assisted distal gastrectomy (LADG). We performed an RCT to confirm if TLDG is different from LADG. METHODS: The XXXXX trial is a multicentre, open-label, parallel-group, phase III, RCT of 442 patients with clinical stage I gastric cancer. Patients were enrolled from 21 cancer care centers in South Korea between January 2018 and September 2020 and randomized to undergo TLDG or LADG using blocked randomization with a 1:1 allocation ratio, stratified by the participating investigators. Patients were treated through R0 resections by TLDG or LADG as the full analysis set of the XXXXX trial. The primary endpoint was morbidity within postoperative day 30, and the secondary endpoint was QoL for 1 year. This trial is registered at ClinicalTrials.gov (NCT XXXXXXXX). RESULTS: 442 patients were randomized (222 to TLDG, 220 to LADG), and 422 patients were included in the pure analysis (213 and 209, respectively). The overall complication rate did not differ between the two groups (TLDG vs. LADG: 12.2% vs. 17.2%). However, TLDG provided less postoperative ileus and pulmonary complications than LADG (0.9% vs. 5.7%, P=0.006; and 0.5% vs. 4.3%, P=0.035, respectively). The QoL was better after TLDG than after LADG regarding emotional functioning at 6 months, pain at 3 months, anxiety at 3 and 6 months, and body image at 3 and 6 months (all P<0.05). However, these QoL differences were resolved at 1 year. CONCLUSIONS: The XXXXX trial confirmed that TLDG is not different from LADG in terms of postoperative complication but has advantages to reduce ileus and pulmonary complications. TLDG can be a good option to offer better QoL in terms of pain, body image, emotion, and anxiety at 3-6 months.

The application of enhanced recovery after surgery protocol after distal gastrectomy for patients with gastric cancer: a prospective randomized clinical trial.

BACKGROUND: This study aimed to evaluate the clinical outcomes and efficacy of enhanced recovery after surgery (ERAS) protocol in patients undergoing distal gastrectomy for gastric cancer (GC). METHODS: Patients were randomly assigned to the ERAS group (EG) and the conventional care group (CG) by stratified randomization according to age and sex. The primary endpoint was adjusted postoperative hospital stay, calculated using discharge criteria developed to evaluate recovery. Nutritional data and quality of life (QoL) (European Organisation for Research and Treatment of Cancer [EORTC] C30 and STO22) during the perioperative period were also analyzed. RESULTS: We enrolled 198 eligible patients with GC for the study between June 2017 and January 2019. A total of 147 patients were finally enrolled in this study (full analysis set) and were assigned to EG (n = 71) and CG (n = 76). First flatus was faster significantly in EG (3.6 ± 1.5 vs 4.1 ± 1.2 days, P = .019). EG showed a faster start of the sips and soft diet than CG (1.3 ± 0.7 vs 3.1 ± 0.4 days, P < .001; 2.4 ± 0.9 vs 5.2 ± 0.7 days, P < .001) according to the protocol. The recorded hospital stay was not significantly different; however, adjusted hospital stay was significantly shorter in EG than in CG (6.5 ± 3.1 vs 7.8 ± 2.1 days, P = .005). There was no difference in morbidity, and no mortality occurred in both groups. EG did not show significant superiority in nutritional outcome and QoL improvement, except for pain scale in EORTC-STO22. CONCLUSION: The application of the ERAS protocol could reduce the adjusted hospital stay without an increase in postoperative complications. There was no significant difference in long-term nutritional outcome and QoL of the 2 groups.

Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen's hernia: a study protocol for a multicenter randomized controlled trial.

BACKGROUND: Petersen's hernia, which occurs after Billroth-II (B-II) or Roux-en-Y (REY) anastomosis, can be reduced by defect closure. This study aims to compare the incidence of bowel obstruction above Clavien-Dindo classification grade III due to Petersen's hernia between the mesenteric fixation method and the conventional methods after laparoscopic or robotic gastrectomy. METHODS: This study was designed as prospective, single-blind, non-inferiority randomized controlled multicenter trial in Korea. Patients with histologically diagnosed gastric cancer of clinical stages I, II, or III who underwent B-II or REY anastomosis after laparoscopic or robotic gastrectomy are enrolled in this study. Participants who meet the inclusion criteria are randomly assigned to two groups: a CLOSURE group that underwent conventional Petersen's defect closure method and a MEFIX group that underwent the mesenteric fixation method. The primary endpoint is the number of patients who underwent surgery for bowel obstruction caused by Petersen's hernia within 3 years after laparoscopic or robotic gastrectomy. DISCUSSION: This trial is expected to provide high-level evidence showing that the MEFIX method can quickly and easily close Petersen's defect without increased postoperative complications compared to the conventional method. TRIAL REGISTRATION: ClinicalTrials.gov NCT05105360. Registered on November 3, 2021.

Reappraisal of optimal reconstruction after distal gastrectomy - a study based on the KLASS-07 database.

BACKGROUNDS: This study aimed to compare the incidence of bile reflux, quality of life (QoL), and nutritional status among Billroth II (BII), Billroth II with Braun anastomosis (BII-B), and Roux-en-Y (RY) reconstruction after laparoscopic distal gastrectomy (LDG). MATERIALS AND METHODS: We reviewed the prospective data of 397 patients from a multicentre database who underwent LDG for gastric cancer between 2018 and 2020 at 20 tertiary teaching hospitals in Korea. Postoperative endoscopic findings, QoL surveys using the European Organization for Research and Treatment of Cancer questionnaire (C30 and STO22), and nutritional and surgical outcomes were compared among groups. RESULTS: In endoscopic findings, bile reflux was the lowest in the RY group ( n =67), followed by the BII-B ( n =183) and BII groups ( n =147) at 1 year (3.0 vs. 67.8 vs. 84.4%, all P <0.05). The anti-reflux capability of BII-B was statistically better than that of BII, but not as perfect as that of RY. From the perspective of QoL, BII-B was not inferior to RY, but better than BII reconstruction in causing fewer STO22 reflux symptoms at 6 and 12 months. However, only RY caused fewer C30 nausea symptoms than BII at 6 and 12 months, but not BII-B. Nutritional status and morbidities were similar among the three groups, and the operative time did not differ between the BII-B and RY groups. CONCLUSIONS: BII-B cannot substitute for RY in preventing bile reflux, shortening the operative time, or reducing morbidities. Regarding short-term QoL, BII-B was sufficient to reduce STO22 reflux symptoms but failed to reduce C30 nausea symptoms postoperatively.

Identifying the best candidates for reduced port gastrectomy.

BACKGROUND: Previous studies have focused on the non-inferiority of RPG compared with conventional port gastrectomy (CPG); however, we assumed that some candidates might derive more significant benefit from RPG over CPG. METHODS: We retrospectively analyzed the clinicopathological and perioperative parameters of 1442 patients with gastric cancer treated by gastrectomy between 2009 and 2022. The C-reactive protein level on postoperative day 3 (CRPD3) was used as a surrogate parameter for surgical trauma. Patients were grouped according to the extent of gastrectomy [subtotal gastrectomy (STG) or total gastrectomy (TG)] and lymph node dissection (D1+ or D2). The degree of surgical trauma, bowel recovery, and hospital stay between RPG and CPG was compared among those patient groups. RESULTS: Of 1442 patients, 889, 354, 129, and 70 were grouped as STGD1+, STGD2, TGD1+, and TGD2, respectively. Compared with CPG, RPG significantly decreased CRPD3 only among patients in the STGD1+ group (CPG: n = 653, 84.49 mg/L, 95% CI 80.53-88.45 vs. RPG: n = 236, 70.01 mg/L, 95% CI 63.92-76.09, P < 0.001). In addition, the RPG method significantly shortens bowel recovery and hospital stay in the STGD1+ (P < 0.001 and P < 0.001), STGD2 (P < 0.001 and P < 0.001), and TGD1+ (P = 0.026 and P = 0.007), respectively. No difference was observed in the TGD2 group (P = 0.313 and P = 0.740). CONCLUSIONS: The best candidates for RPG are patients who undergo STGD1+, followed by STGD2 and TG D1+, considering the reduction in CRPD3, bowel recovery, and hospital stay.

Small bowel diaphragm disease with multiple cluster lesions in one segment of the small bowel mimicking an adhesion band: A case report.

RATIONALE: Small bowel diaphragm disease (SBDD) is a rare case, caused by long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs). The circumferential diaphragm in the lumen of small bowel causing mechanical obstruction is the characteristic finding. PATIENT CONCERNS: A 74-year-old male was transferred to Pusan National University Yangsan Hospital (PNUYH) due to abdominal pain lasting for 2 months. He was treated in the local medical center (LMC) with Levin tube insertion and Nil Per Os (NPO) but showed no improvement. DIAGNOSIS: According to abdomen-pelvis computed tomography (CT) result, small bowel obstruction due to the adhesion band was identified, showing dilatation of the small bowel with abrupt narrowing of the ileum. INTERVENTIONS: Laparoscopic exploration was done but failed to find an adhesion band. An investigation of the whole small bowel was done with mini-laparotomy. At the transitional zone, the intraluminal air could not pass so the segmental resection of small bowel including the transitional zone and end-to-end anastomosis was done. OUTCOMES: After surgery, every laboratory finding recovered to the normal range in 4 days, but the patient's ileus lasted for 8 days. The patient's symptoms were relieved after defecation, he was discharged on postoperative day 10. LESSONS: For patients who show mechanical obstruction without an operation history but with long-term administration of NSAIDs, the clinicians should suspect small bowel diaphragm disease.

Clinical strategies for securing negative proximal margin in early gastric cancer.

Securing an appropriate proximal resection margin (PRM) is crucial for oncological safety in treating gastric cancer. This study investigated the clinicopathological characteristics of patients with incomplete PRM length of <2 cm in early gastric cancer. Clinicopathological data of 1,493 patients who underwent subtotal gastrectomy for early gastric cancer in 2012 to 2021 were retrospectively reviewed. Patients were divided into the PRM length of <2 cm and ≥2 cm groups based on pathological results. Univariate and multivariate analyses evaluated factors for incomplete PRM length. Factors related to patients with a relative PRM positive were also analyzed. The proportion of patients with a PRM length of <2 cm was 17.9% (267/1,493). Multivariate regression analysis revealed that age <50, preoperative endoscopic size of ≥3 cm, size discrepancy of ≥2 cm, and midbody tumor with a lesser curvature significantly contributed to the PRM length of <2 cm. Twenty-four patients had a relative PRM positive (24/1493, 1.6%). An incomplete PRM was the only risk factor for a positive relative PRM. Surgical treatment for early gastric cancer requires an accurate preoperative endoscopic tumor size and location evaluation. A more aggressive resection is recommended for patients with age <50, preoperative endoscopic size of ≥3 cm, size discrepancy of ≥2 cm, and midbody tumor with a lesser curvature.

Local Recurrence after Endoscopic Submucosal Dissection of Early Gastric Cancer.

Endoscopic submucosal dissection (ESD) is considered the treatment of choice for early gastric cancer (EGC) with a negligible risk of lymph node metastasis. Locally recurrent lesions on artificial ulcer scars are difficult to manage. Predicting the risk of local recurrence after ESD is important to manage and prevent the event. We aimed to elucidate the risk factors associated with local recurrence after ESD of EGC. Between November 2008 and February 2016, consecutive patients (n = 641; mean age, 69.3 ± 9.5 years; men, 77.2%) with EGC who underwent ESD at a single tertiary referral hospital were retrospectively analyzed to evaluate the incidence and factors associated with local recurrence. Local recurrence was defined as the development of neoplastic lesions at or adjacent to the site of the post-ESD scar. En bloc and complete resection rates were 97.8% and 93.6%, respectively. The local recurrence rate after ESD was 3.1%. The mean follow-up period after ESD was 50.7 ± 32.5 months. One case of gastric cancer-related death (0.15%) was noted, wherein the patient had refused additive surgical resection after ESD for EGC with lymphatic and deep submucosal invasion. Lesion size ≥15 mm, incomplete histologic resection, undifferentiated adenocarcinoma, scar, and the absence of erythema of the surface were associated with a higher risk of local recurrence. Predicting local recurrence during regular endoscopic surveillance after ESD is important, especially in patients with a larger lesion size (≥15 mm), incomplete histologic resection, surface changes of scars, and no erythema of the surface.

Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12 Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial.

Importance: Patients undergoing proximal gastrectomy (PG) with double-tract reconstruction (DTR) have been reported to have an incidence of reflux esophagitis that is as low as that observed after total gastrectomy (TG). It is unclear whether PG has an advantage over TG for the treatment of patients with upper early gastric cancer (GC). Objective: To evaluate the effect of laparoscopic PG with DTR (LPG-DTR) vs laparoscopic TG (LTG) on levels of hemoglobin and vitamin B12 supplementation required among patients with clinically early GC in the upper third of the stomach (upper-third early GC). Design, Setting, and Participants: This multicenter open-label superiority randomized clinical trial was conducted at 10 institutions in Korea. A total of 138 patients with upper-third cT1N0M0 GC were enrolled between October 27, 2016, and September 9, 2018. Follow-up ended on December 3, 2020. Interventions: Patients were randomized to undergo either LPG-DTR or LTG. Main Outcomes and Measures: The primary co-end points were change in hemoglobin level and cumulative amount of vitamin B12 supplementation at 2 years after LPG-DTR or LTG. The secondary end points included morbidity, postoperative reflux esophagitis, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months. Results: Among 138 patients (mean [SD] age, 60.0 [10.9] years; 87 men [63.0%]; all of Asian race and Korean ethnicity), 68 (mean [SD] age, 56.7 [10.4] years; 39 men [57.4%]) were randomized to receive LPG-DTR and 69 (mean [SD] age, 61.3 [11.3] years; 48 men [69.6%]) were randomized to receive LTG. The mean (SD) changes in hemoglobin levels from baseline to month 24 were -5.6% (7.4%) in the LPG-DTR group and -6.9% (8.3%) in the LTG group, for an estimated difference of -1.3% (95% CI, -4.0% to 1.4%; P = .35). The mean (SD) cumulative amount of vitamin B12 supplementation was 0.4 (1.3) mg in the LPG-DTR group and 2.5 (3.0) mg in the LTG group, for an estimated difference of 2.1 mg (95% CI, 1.3-2.9 mg; P < .001). The late complication rates in the LPG-DTR and LTG groups were 17.6% and 10.1%, respectively (P = .31). The incidence of reflux esophagitis was not different between the LPG-DTR and LTG groups (2.9% vs 2.9%; P = .99). Compared with the LTG group, the LPG-DTR group had better physical functioning scores (85.2 [15.6] vs 79.9 [19.3]; P = .03) and social functioning scores (89.5 [17.9] vs 82.4 [19.4]; P = .03) on the EORTC QLQ-C30. Two-year overall survival (98.5% vs 100%; P = .33) and disease-free survival (98.5% vs 97.1%; P = .54) did not significantly differ between the LPG-DTR vs LTG groups. Conclusions and Relevance: In this study, patients with upper-third early GC who received LPG-DTR required less vitamin B12 supplementation than those who received LTG, with no increase in complication rates and no difference in overall and disease-free survival rates. There was no difference in change in hemoglobin level between groups. In addition, the LPG-DTR group had better physical and social functioning than the LTG group. These findings suggest that LPG-DTR may be as safe as LTG and may be a function-preserving procedure for the treatment of patients with upper-third early GC. Trial Registration: ClinicalTrials.gov Identifier: NCT02892643.

Application of the Falciform Ligament Patch for the Prevention of Duodenal Stump Leakage After Gastrectomy: Technical Report on a Case Series.

Background: Duodenal stump leakage (DSL) is a serious complication after gastrectomy. In this study, we developed a novel prevention technique using a falciform ligament patch (FLP) to prevent DSL among high-risk patients after gastrectomy. Materials and Methods: From January 2019 to July 2021, 14 patients who were judged to be at high risk for DSL during preoperative examinations or surgery were included in this retrospective study, and the FLP was applied to the duodenal stump. The falciform ligament was separated from the liver after duodenal transection during gastrectomy; the end part was used to cover the duodenal stump and was fixed using nonabsorbable polypropylene sutures. Results: In total, 14 patients who underwent FLP had one or two risk factors that were identified: 5 patients, gastric cancer duodenal invasion; 4 patients, gastric outlet obstruction (GOO); 1 patient, cancer involving the distal resection margin; 1 patient, duodenal gastrointestinal stromal tumor involving the distal resection margin; 1 patient, gastric cancer duodenal invasion and GOO; and 2 patients, cancer involving the distal resection margin and GOO. FLP construction was successful, and no patient developed complications of DSL. The average hospital stay was 11.9 days, and the patients were discharged without any morbidities after surgery. Conclusions: Therefore, the FLP can be used to prevent DSL among high-risk patients after gastrectomy.

Clinical outcomes of gastroduodenal neuroendocrine tumors according to their WHO grade: A single-institutional retrospective analysis.

The management of gastroduodenal neuroendocrine tumor (NET) has been controversial between radical surgical resection and local excision including endoscopic resection. A gastroduodenal NET grade (G), measured by their mitotic rate and Ki67 proliferation index, is important to predict prognosis. In this study, we aimed to compare the clinical outcomes of gastroduodenal NET according to grades in order to identify poor prognostic factors of gastroduodenal NETs. Fifty-four gastroduodenal NETs diagnosed between December 2008 and December 2020 in a tertiary referral hospital were retrospectively reviewed. The clinical outcomes of gastroduodenal NETs, according to tumor grades and factors associated with NET G2-3, were analyzed. A total of 52 gastroduodenal NET patients was enrolled. The mean follow-up period was 56.2 ± 40.1 months. The mean size of gastric and duodenal NET was 7.9 ± 11.0 mm and 9.8 ± 7.6 mm, respectively. During the study period, 72.7% (16/22) of gastric NETs and 83.3% (25/30) of duodenal NETS were G1. All G1 gastroduodenal NETs showed no lymph node or distant metastasis during the study periods. All G3 gastroduodenal NETs showed metastasis (one lymph node metastasis and 3 hepatic metastases). Among metastatic NETs, the smallest tumor size was a 13 mm gastric G3 NET. Factors associated with G2-3 NETs were larger tumor size, mucosal ulceration, proper muscle or deeper invasion, and lymphovascular invasion. A small-sized gastroduodenal NET confined to submucosa without surface ulceration may be suitable for endoscopic resection. After local resection of a gastroduodenal NET (G1) without lymphovascular and muscle proper invasion, follow-up examination without radical surgical resection can be recommended. G3 NETs may be treated by radical surgical resection, regardless of tumor size.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial.

PURPOSE: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. MATERIALS AND METHODS: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. RESULTS: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. CONCLUSIONS: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02892643.

A 3-year follow-up study of uncut Roux-en-Y reconstruction: clinical results and outcomes.

BACKGROUND: The goal of this study was to identify the clinical outcomes of uncut Roux-en-Y reconstruction in patients who underwent totally laparoscopic distal gastrectomy (TLDG) over 3-year follow-up. METHODS: From January 2016 to December 2017, 269 patients who underwent TLDG were enrolled in the study and analyzed retrospectively. They were classified into two groups according to the reconstruction method: uncut Roux-en-Y reconstruction (uncut RY) (n = 154) and Billroth II with Braun anastomosis (B-II/Braun) (n = 115). Postoperative endoscopic findings (residual food, bile reflux, gastritis, and esophagitis) and nutritional status (body weight, serum hemoglobin, total protein, and albumin levels) were assessed every 6 months for 3 years. RESULTS: Residual food was less frequent in the uncut RY group in the 6th month after TLDG (p = 0.022), but there were no differences between the two groups for the rest of the study period. The incidence of bile reflux and gastritis was low in the uncut RY group during all postoperative periods (all p < 0.001). In the B-II/Braun group, the frequency of reflux esophagitis was high in the 30th and 36th months after TLDG (both p < 0.001), and there were no differences between the two groups during the preceding periods. No significant differences were found with respect to nutritional status, such as body weight, serum hemoglobin, total protein, and albumin levels during all postoperative periods. CONCLUSIONS: Three-year follow-up outcomes showed that uncut RY can effectively reduce the incidence of bile reflux and gastritis in the remnant stomach compared to B-II/Braun after TLDG.

Long-Term Survival Outcomes of Elderly Patients Treated With S-1 or Capecitabine Plus Oxaliplatin for Stage II or III Gastric Cancer: A Multicenter Cohort Study.

Purpose: Tegafur/gimeracil/oteracil (S-1) and capecitabine plus oxaliplatin (CAPOX) are standard adjuvant chemotherapies (ACs) administered after gastrectomy to patients with stage II or III gastric cancer. However, the efficacy of AC in elderly patients remains unclear. The objective of this retrospective multicenter cohort study was to compare the efficacies of S-1 and CAPOX AC in patients aged ≥70 years. Materials and Methods: Nine hundred eighty-three patients who were treated with AC using S-1 (768 patients) or CAPOX (215 patients) were enrolled in this study. Each patient underwent AC after curative gastrectomy for stage II or III gastric cancer at one of 27 hospitals in the Republic of Korea between January 2012 and December 2013. Relapse-free survival (RFS) and overall survival (OS) were analyzed according to AC regimen and age group. Results: Of the 983 patients, 254 (25.8%) were elderly. This group had a similar RFS (P=0.099) but significantly poorer OS (p=0.003) compared with the non-elderly group. Subgroup analysis of the non-elderly group revealed no AC-associated differences in survival. Subgroup analysis of the elderly group revealed significantly better survival in the S-1 group than in the CAPOX group (RFS, P<0.001; OS, P<0.001). Multivariate analysis revealed that the CAPOX regimen was an independent poor prognostic factor for RFS (hazard ratio [HR], 1.891; 95% confidence interval [CI], 1.072-3.333; P=0.028) and OS (HR, 2.970; 95% CI, 1.550-5.692; P=0.001). Conclusions: This multicenter observational cohort study found significant differences in RFS and OS between S-1 and CAPOX AC among patients with gastric cancer aged ≥70 years.

Actual 3-Year Survival After Reduced-Port Laparoscopic Distal Gastrectomy for Gastric Cancer (RpLDG): a Propensity Score Matching Analysis.

BACKGROUND: Total laparoscopic distal gastrectomy for early gastric cancer has been widely accepted; however, reduced-port laparoscopic distal gastrectomy has not gained the same popularity because of technical difficulties and oncologic safety issues. This study aimed to analyze the oncologic safety and short-term surgical outcomes of patients who underwent reduced-port laparoscopic distal gastrectomy (RpLDG) for gastric cancer. METHODS: Consecutive patients who underwent surgical treatment between January 2016 and May 2018 were included in this study. Of the 833 patients enrolled, 158 underwent RpLDG and were propensity-matched with 158 patients who underwent conventional port laparoscopic distal gastrectomy (CpLDG). The groups were compared in terms of short-term outcomes and disease-free and overall survival rates. RESULTS: The RpLDG group had shorter operation times (161.8 min vs. 189.0 min, p < 0.00) and shorter postoperative hospital stays (7.6 days vs. 9.1 days, p = 0.04) compared to the CpLDG group. Estimated blood loss was lower in the RpLDG group than in the CpLDG group (52.6 mL vs. 73.7 mL, p < 0.00), while hospital costs incurred by the RpLDG group were lower than those of the CpLDG group (10,033.7 vs. 11,016.8 USD, p < 0.00). No statistical differences were found regarding overall morbidity and occurrence of surgical complications of grade III or higher, as defined by the Clavien-Dindo classification. Furthermore, no significant differences between RpLDG and CpLDG were found in 3-year disease-free (99.4% vs. 98.1%; p = 0.42) and 3-year overall survival rates (98.7% vs. 96.8%; p = 0.25). CONCLUSION: Patients who underwent RpLDG had better short-term surgical outcomes than those who underwent CpLDG in terms of operation time, estimated blood loss, duration of hospital stay, and hospital costs. The oncologic safety of RpLDG was satisfactory.

Appropriate Number of Adjuvant Chemotherapy Cycles for Patients with Stage 2 or 3 Gastric Cancer After Curative Gastrectomy: A Multicenter Cohort Study.

BACKGROUND: Few studies have presented evidence pertaining to the adequate minimum number of adjuvant chemotherapy (AC) cycles required to achieve an oncologic benefit for gastric cancer. METHODS: From January 2012 to December 2013, data from patients who underwent curative radical gastrectomy and consequently received AC for pathologic stage 2 or 3 gastric cancer at 27 institutions in South Korea were analyzed. RESULTS: The study enrolled 925 patients, 661 patients (71.5%) who completed 8 cycles of AC and 264 patients (28.5%) who did not. Compared with the mean disease-free survival (DFS) of the patients who completed 8 AC cycles (69.3 months), the mean DFS of patients who completed 6 AC cycles (72.4 months; p = 0.531) and those who completed 7 AC cycles (63.7 months; p = 0.184) did not differ significantly. However, the mean DFS of the patients who completed 5 AC cycles (48.2 months; p = 0.016) and those who completed 1-4 AC cycles (62.9 months; p = 0.036) was significantly lower than the DFS of those who completed 8 AC cycles. In the multivariate Cox proportional hazards analysis, the mean DFS was significantly affected by advanced stage, large tumor size, positive vascular invasion, and number of completed AC cycles (1-5 cycles: hazard ratio 1.45; 95% confidence interval 1.01-2.08; p = 0.041). CONCLUSION: The current multicenter observational cohort study showed that the mean DFS for 6 or 7 AC cycles was similar to that for 8 AC cycles as an adjuvant treatment for gastric cancer.

Clinical features of internal hernia after gastrectomy for gastric cancer.

Purpose: Internal hernia after gastrectomy is a rare but potentially life-threatening condition without surgical intervention. Clinical risk factors of internal hernia should, hence, be reviewed after gastrectomy. From 2008 to 2018, patients who underwent gastrectomy for gastric cancer were investigated. Methods: Abdominal computed tomography (CT) was used to screen for internal hernia, and surgical exploration was performed to confirm the diagnosis. Using retrospective statistical analysis, the incidence, characteristics, and risk factors were identified, and the characteristics of the internal hernia group were reviewed. Results: The overall incidence of internal hernia was 0.9%. From statistical analysis, it was found that laparoscopic surgery was almost five times riskier than open gastrectomy (odds ratio [OR], 4.947; 95% confidence interval [CI], 1.308-18.710; p = 0.019). Body mass index < 25 kg/m2 (OR, 4.596; 95% CI, 1.056-20.004; p = 0.042) and proximal gastrectomy (OR, 4.238; 95% CI, 1.072-16.751; p = 0.039) were also associated with internal hernia. Among 20 patients with internal hernia, 12 underwent laparotomy, and five had their bowels removed due to ischemia. All patients with bowel resected had suffered from short bowel syndrome. Conclusion: Suspecting an internal hernia should be an important step when a patient with a history of laparoscopic gastrectomy visits for medical care. When suspected, emergent screening through CT scan and surgical intervention should be considered as soon as possible to prevent lifetime complications accordingly.

Comparison of surgical outcomes among different methods of esophagojejunostomy in laparoscopic total gastrectomy for clinical stage I proximal gastric cancer: results of a single-arm multicenter phase II clinical trial in Korea, KLASS 03.

BACKGROUND: Laparoscopic distal gastrectomy for early gastric cancer has been widely accepted, but laparoscopic total gastrectomy has still not gained popularity because of technical difficulty and unsolved safety issue. We conducted a single-arm multicenter phase II clinical trial to evaluate the safety and the feasibility of laparoscopic total gastrectomy for clinical stage I proximal gastric cancer in terms of postoperative morbidity and mortality in Korea. The secondary endpoint of this trial was comparison of surgical outcomes among the groups that received different methods of esophagojejunostomy (EJ). METHODS: The 160 patients of the full analysis set group were divided into three groups according to the method of EJ, the extracorporeal circular stapling group (EC; n = 45), the intracorporeal circular stapling group (IC; n = 64), and the intracorporeal linear stapling group (IL; n = 51). The clinicopathologic characteristics and the surgical outcomes were compared among these three groups. RESULTS: There were no significant differences in the early complication rates among the three groups (26.7% vs. 18.8% vs. 17.6%, EC vs. IC vs. IL; p = 0.516). The length of mini-laparotomy incision was significantly longer in the EC group than in the IC or IL group. The anastomosis time was significantly shorter in the EC group than in the IL group. The time to first flatus was significantly shorter in the IL group than in the EC group. The long-term complication rate was not significantly different among the three groups (4.4% vs. 12.7% vs. 7.8%; EC vs. IC vs. IL; p = 0.359), however, the long-term incidence of EJ stenosis in IC group (10.9%) was significantly higher than in EC (0%) and IL (2.0%) groups (p = 0.020). CONCLUSIONS: The extracorporeal circular stapling and the intracorporeal linear stapling were safe and feasible in laparoscopic total gastrectomy, however, intracorporeal circular stapling increased EJ stenosis.

Reduced fasting time in patients who underwent totally laparoscopic distal gastrectomy.

PURPOSE: The aim of this study was to analyze the effects of reduced fasting time on postoperative recovery in patients who underwent totally laparoscopic distal gastrectomy (TLDG). METHODS: This retrospective study included 347 patients who underwent TLDG. Patients were divided into 2 groups: reduced fasting time group (n = 139) and conventional feeding group (n = 208). We compared the total hospital cost and recovery parameters, such as postoperative complications, mean hospital stay, day of first flatus, initiation of soft diet, and serum CRP levels, between the 2 groups. RESULTS: The reduced fasting time group had a lower total hospital cost (P < 0.001) than the conventional feeding group. Regarding postoperative complications, there was no significant difference between the 2 groups (P = 0.085). Patients in the reduced fasting time group had a significantly shorter duration of mean hospital stay (P < 0.001), an earlier first flatus (P = 0.002), an earlier initiation of soft diet (P < 0.001), and lower level of serum CRP concentration (day of surgery, P = 0.036; postoperative days 2, 5, and 7, P = 0.01, 0.009, and 0.012, respectively) than patients in the conventional feeding group. CONCLUSION: Reduced fasting time can enhance postoperative recovery in patients who undergo TLDG and may reduce medical costs.

Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial.

Importance: The incidence of gallstones has been reported to increase after gastrectomy. However, few studies have been conducted on the prevention of gallstone formation in patients who have undergone gastrectomy. Objective: To evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing gallstone formation after gastrectomy in patients with gastric cancer. Design, Setting, and Participants: The PEGASUS-D study (Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study) was a randomized, double-blind, placebo-controlled clinical trial conducted at 12 institutions in the Republic of Korea. Adults (aged ≥19 years) with a diagnosis of gastric cancer who underwent total, distal, or proximal gastrectomy were enrolled between May 26, 2015, and January 9, 2017; follow-up ended January 8, 2018. Efficacy was evaluated by both the full analysis set, based on the intention-to-treat principle, and the per-protocol set; full analysis set findings were interpreted as the main results. Interventions: Eligible participants were randomly assigned to receive 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1. Ursodeoxycholic acid and placebo were administered daily for 52 weeks. Main Outcomes and Measures: Gallstone formation was assessed with abdominal ultrasonography every 3 months for 12 months. Randomization and allocation to trial groups were carried out by an interactive web-response system. The primary end point was the proportion of patients developing gallstones within 12 months after gastrectomy. Results: A total of 521 patients (175 received 300 mg of UDCA, 178 received 600 mg of UDCA, and 168 received placebo) were randomized. The full analysis set included 465 patients (311 men; median age, 56.0 years [interquartile range, 48.0-64.0 years]), with 151 patients in the 300-mg group, 164 patients in the 600-mg group, and 150 patients in the placebo group. The proportion of patients developing gallstones within 12 months after gastrectomy was 8 of 151 (5.3%) in the 300-mg group, 7 of 164 (4.3%) in the 600-mg group, and 25 of 150 (16.7%) in the placebo group. Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group. No significant adverse drug reactions were detected among the enrolled patients. Conclusions and Relevance: Administration of UDCA for 12 months significantly reduced the incidence of gallstones after gastrectomy for gastric cancer. These findings suggest that UDCA administration prevents gallstone formation after gastrectomy in patients with gastric cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02490111.