Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial).

PURPOSE: We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. METHODS AND METHODS: The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively. RESULTS: The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group. CONCLUSIONS: Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03393182.

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 KLASS-07 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 KLASS-07 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 NCT03393182). 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 KLASS-07 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.

Nomogram for Predicting Infectious Complications Following Curative Gastrectomy Using Clinical and Laboratory Parameters.

BACKGROUND/AIM: Postoperative infectious complications are prevalent and significantly impact the prognosis and hospital stay duration after curative gastrectomy. This study aimed to identify predictive factors and develop a nomogram for predicting infectious complications prior to patient discharge. PATIENTS AND METHODS: Between April 2019 and December 2023, clinicopathological data of 237 patients with gastric cancer who underwent curative gastrectomy at the Eunpyeong St. Mary's Hospital were retrospectively reviewed. C-reactive protein (CRP), white blood cell (WBC) count, neutrophil-lymphocyte ratio (NLR), and procalcitonin (PCT) levels were analyzed. RESULTS: Overall, 58 patients experienced postoperative complications, with 33 patients developing infectious complications. Univariate analysis revealed that the open approach, esophagus involving resection, advanced stage, and operation time were risk factors for infectious complications among clinicopathologic characteristics. Significant associations with laboratory parameters and body temperature (BT) were observed from postoperative day (POD) 1 to 5, with the highest area under the curve (AUC) observed for POD 5 data in receiver operating characteristic (ROC) analysis. Multivariate analysis incorporating clinicopathologic features and laboratory parameters on POD 5 identified age (OR=2.98), approach (OR=4.05), operation time (OR=2.74), WBC count (OR=4.09), NLR (OR=9.74), and CRP (OR=2.62) as selected factors. The developed nomogram stratified patients into low-risk (<10%), intermediate-risk (10~50%), and high-risk (≥50%) groups, corresponding to actual infectious complication rates of 1.84%, 28.3%, and 71.43%, respectively. CONCLUSION: This study presents a novel estimating model for infectious complications following curative gastrectomy. The utilization of this model in patient discharge planning can aid in identifying individuals who require additional treatment, thereby minimizing unexpected readmissions.

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.

Case Report: Severe osteoporosis misunderstood by bone metastasis after total gastrectomy and multiple metastasectomy.

After radical gastrectomy for gastric cancer, patients should be monitored from two perspectives. One is local recurrence or metastasis, and the other is nutritional and metabolic side effects. Herein, we report a case of severe osteoporosis that was misunderstood for bone metastasis due to increased bone scan and positron emission tomography-computed tomography uptake in the patient who underwent total gastrectomy and consecutive multivisceral metastasectomy. She was administered bisphosphonates, calcium carbonate, and cholecalciferol. After 3 months, a follow-up bone scan revealed decreased intensity of hot-uptake lesions, healed fracture lesions, and eventually improved bone pain. This study supports the need for careful nutritional screening as well as cancer surveillance after gastrectomy for gastric cancer and the need for screening guidelines for bone metabolic diseases.

Current Status of Bariatric and Metabolic Surgery in Daejeon and Chungcheong Province: Early Experiences after Public Medical Insurance Coverage in 2019.

Purpose: This study aimed to investigate the current status of bariatric and metabolic surgery in Daejeon and Chungcheong province and to describe the early experiences after public medical insurance coverage in 2019. Materials and Methods: Between January 2019 and August 2019, 64 cases of bariatric and metabolic surgery were performed in patients with morbid obesity or uncontrolled type 2 diabetes. We prospectively collected and analyzed data regarding the patients' demographics and comorbidities, surgical results, and early complications. The patient information before and after the insurance coverage was also compared. Results: The number of surgeries in 9 years has been caught up only in the last 8 months after insurance coverage (58 vs. 64 patients). The mean body mass index was 37.7±5.8 kg/m2 (range, 22.7-52.1 kg/m2). The most frequently performed surgery was sleeve gastrectomy (53 cases, 82.8%), followed by Roux-en-Y gastric bypass (9 cases, 14.1%), and adjustable gastric banding (2 cases, 3.1%). Postoperative complications occurred in 6 patients (9.4%), and there was no mortality. The mean operation time (225.3±85.4 vs. 156.1±61.8 min, P<0.001) and postoperative stay (5.9±4.5 vs. 4.3±2.0 days, P=0.013) after the insurance coverage were significantly shorter than those before the insurance coverage. Conclusion: We could assess the patients who had bariatric and metabolic surgery in Daejeon and Chungcheong province after public medical insurance coverage in 2019.

Unexpected Pathologic Diagnosis of the Mitral Valvular Mass.

A 59-year-old man with multifocal cerebral infarction was found to have the large obstructive mitral valvular mass. Although benign tumor was under suspicion before surgery, he was finally diagnosed as chronic infective endocarditis by microscopic evaluation. The precise diagnosis and the proper management of a cardiac mass are very important since even the benign tumor may cause fatal complications. However, primary cardiac mass has the broad spectrum from pseudo-tumor to malignancy and the differential diagnosis using non-invasive methods is not easy even with the currently available imaging techniques.