Hepatogastric fistula: a complication of pyogenic liver abscess in a patient with the Brugarda syndrome - A rare case report.

Hepatogastric fistula following pyogenic liver abscess (PLA) is a rare and fatal complication, and only a handful of cases have been reported without co-existing comorbidities of Brugarda syndrome. Case presentation: A 22-year-old male presented to the emergency room with a known case of Brugarda pattern ECG with chief complaints of on-and-off abdominal pain and fever for 2 weeks and shortness of breath for one day. On evaluation, echocardiography showed a clot in the inferior vena cava (IVC) and right atrium (RA), and on computed tomography scan of the abdomen revealed a liver abscess with transmural gastric perforation. During, an exploratory laparotomy where a fistula joining the left lobe of the liver and stomach was detected, and an emergency excision was done. The patient was shifted to the ICU and later developed septic shock, which was managed medically. Clinical discussion: Usually, thrombosis of the portal vein and the hepatic vein is a very common complication of a PLA but vascular complications like IVC, RA thrombosis, and hepatogastric fistula have been reported rarely. Our case is peculiar hepatogastric fistulization along with IVC/RA clots in a patient with Brugarda pattern ECG. The typical clinical manifestation of a patient with hepatogenic fistula is absent in our patient and presented with an on-off type of fever, epigastric pain, and shortness of breath and was managed surgically. Conclusion: Hepatogasric fistula, thrombosis of the IVC, and RA are a rare complications of PLA. The patient with Brugarda syndrome is at high risk as its clinical manifestation gets exaggerated during sepsis.

Sintilimab combined neoadjuvant intraperitoneal and systemic chemotherapy in gastric cancer with peritoneal metastasis.

Intraperitoneal chemotherapy combined with systemic chemotherapy is one of the therapeutic modalities currently used for the treatment of gastric cancer patients with peritoneal metastasis. This study was designed to evaluate the efficacy and safety of sintilimab plus S-1 combined intraperitoneal and intravenous paclitaxel. This is an open-label, single-center, phase II study including 36 gastric adenocarcinoma patients with peritoneal metastases diagnosed by laparoscopy. All enrolled patients received sintilimab, intraperitoneal and intravenous paclitaxel plus oral S-1 every 3 weeks. Conversion operation should be considered when a patient responds to the regimen and the peritoneal metastasis disappears. After gastrectomy, the protocol treatment is repeated until disease progression, unacceptable toxicity, investigator decision or patient withdrawal. The primary end point is the 1-year survival rate. Clinical Trial Registration: NCT05204173 (ClinicalTrials.gov).

Effect of glycopyrrolate on vasopressor requirements for non-elective cesarean section under spinal anesthesia: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: The study aimed to investigate whether prophylactic use of glycopyrrolate decreases the vasopressor requirements to prevent hypotension following spinal anesthesia during non-elective cesarean section. METHOD: In this double-blind randomized clinical trial, 258 patients undergoing non-elective cesarean section were randomly assigned (1:1) to receive intravenous 0.2 mg glycopyrrolate or normal saline (placebo) before spinal anesthesia. The primary outcome was phenylephrine equivalent needed intraoperatively. Secondary outcomes included incidences of maternal hypotension, reactive hypertension, bradycardia, need for atropine, tachycardia, intraoperative nausea/vomiting, shivering, pruritus, dry mouth, dizziness; neonatal APGAR score at 1 min and 5 min, neonatal resuscitation needed, NICU admission and neonatal death. RESULTS: Three patients withdrew from the study due to failed spinal anesthesia. 128 patients in the glycopyrrolate group and 127 patients in the placebo group were analyzed. The mean phenylephrine equivalent needed was 1108.96 µg in the glycopyrrolate group and 1103.64 µg in the placebo group (mean difference, 5.32 µg [95% CI - 67.97 to 78.62]; P = 0.88). Hypotension occurred in 38 patients (30%) in the glycopyrrolate group as compared with 49 patients (39%) in the placebo group (P = 0.13). Tachycardia was reported in 70% of the participants in the glycopyrrolate group and 57% of those in the placebo group (P = 0.04). No statistically significant difference was noted in hypotensive episodes > 1, reactive hypertension, bradycardia, need for atropine, nausea, vomiting, shivering, and dry mouth between the two groups. Neonatal outcomes were similar in the two groups. CONCLUSION: Prophylactic use of glycopyrrolate does not decrease the requirements of vasopressor to prevent hypotension in non-elective cesarean section under spinal anesthesia. TRIAL REGISTRATION: Registration number: NCT04401345. Date of registration: 26/05/2020. Website: https://clinicaltrials.gov.

CT-Based Radiomics Showing Generalization to Predict Tumor Regression Grade for Advanced Gastric Cancer Treated With Neoadjuvant Chemotherapy.

Objective: The aim of this study was to develop and validate a radiomics model to predict treatment response in patients with advanced gastric cancer (AGC) sensitive to neoadjuvant therapies and verify its generalization among different regimens, including neoadjuvant chemotherapy (NAC) and molecular targeted therapy. Materials and Methods: A total of 373 patients with AGC receiving neoadjuvant therapies were enrolled from five cohorts. Four cohorts of patients received different regimens of NAC, including three retrospective cohorts (training cohort and internal and external validation cohorts) and a prospective Dragon III cohort (NCT03636893). Another prospective SOXA (apatinib in combination with S-1 and oxaliplatin) cohort received neoadjuvant molecular targeted therapy (ChiCTR-OPC-16010061). All patients underwent computed tomography before treatment, and thereafter, tumor regression grade (TRG) was assessed. The primary tumor was delineated, and 2,452 radiomics features were extracted for each patient. Mutual information and random forest were used for dimensionality reduction and modeling. The performance of the radiomics model to predict TRG under different neoadjuvant therapies was evaluated. Results: There were 28 radiomics features selected. The radiomics model showed generalization to predict TRG for AGC patients across different NAC regimens, with areas under the curve (AUCs) (95% interval confidence) of 0.82 (0.76~0.90), 0.77 (0.63~0.91), 0.78 (0.66~0.89), and 0.72 (0.66~0.89) in the four cohorts, with no statistical difference observed (all p > 0.05). However, the radiomics model showed poor predictive value on the SOXA cohort [AUC, 0.50 (0.27~0.73)], which was significantly worse than that in the training cohort (p = 0.010). Conclusion: Radiomics is generalizable to predict TRG for AGC patients receiving NAC treatments, which is beneficial to transform appropriate treatment, especially for those insensitive to NAC.

A phase III trial of neoadjuvant intraperitoneal and systemic chemotherapy for gastric cancer with peritoneal metastasis.

Although recent advances in systemic chemotherapy have improved the clinical outcomes of gastric cancer patients with peritoneal metastasis, the peritoneum still represents a common site of treatment failure and disease recurrence. Neoadjuvant intraperitoneal-systemic chemotherapy has been acknowledged as a more aggressive treatment for gastric cancer patients with peritoneal metastasis. In this multicenter phase III randomized controlled trial, 238 patients will be randomly separated into two groups in a 2:1 ratio after laparoscopic exploration. The experimental arm will receive the proposed neoadjuvant intraperitoneal-systemic chemotherapy regimen, whereas the control group will receive a Paclitaxel + S-1 (PS) chemotherapy regimen. The endpoints for the study are overall survival, response rate, gastrectomy radicality rate, progression-free survival and adverse events.

Recent advances in technology have improved the outcomes of stomach cancer patients. However, there are still many patients who die of cancer that has spread from another part of the body. Neoadjuvant intraperitoneal­systemic chemotherapy has been acknowledged as a more aggressive treatment for stomach cancer patients with peritoneal metastasis (cancer that has spread to the very thin layer of tissue on the inside of the abdomen that covers the stomach and other organs). In this study, 238 patients will be randomly separated into two groups in a 2:1 ratio after evaluation. The experimental group will receive the proposed neoadjuvant intraperitoneal­systemic chemotherapy regimen, whereas the control group will receive a Paclitaxel + S-1 (PS) chemotherapy regimen. The endpoints for the study are how long patients live, number of patients who respond to treatment, number of patients who undergo surgery, how long patients live without their disease getting worse and problems caused by treatment. Trial registration number: ChiCTR-IIR-16009802.

A phase II study of perioperative treatment in gastric cancer with No.16a2/b1 lymph node metastasis: DRAGON-06 trial.

Although gastric cancer with para-aortic lymph node (PAN) metastasis is commonly regarded as unresectable, surgeons have explored the optimal treatment for patients with PAN metastases limited to No.16a2/b1 in the past few decades. Preoperative systemic therapy combined with D2 gastrectomy plus PAN dissection may improve the prognosis of these patients. In this multicenter phase II trial, 29 gastric cancer patients with PAN metastasis limited to No.16a2/b1 will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 (nab-POS: nab-paclitaxel, oxaliplatin, S-1) and sintilimab followed by D2 gastrectomy plus PAN dissection; and postoperative treatment with oral S-1, intravenous sintilimab and intraperitoneal paclitaxel. The end points for the study are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events.

Stomach cancer with metastases in the para-aortic lymph nodes is usually considered inoperable. Chemotherapy combined with resection of the stomach and more extensive lymph node dissection may prolong the life of these patients. In this multicenter study, 29 stomach cancer patients with para-aortic lymph node metastases will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 and sintilimab, followed by resection of the stomach combined with para-aortic lymph node dissection and use of continued oral, intravenous and intraperitoneal chemotherapy. The study's end points are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events. Clinical Trial Registration: ChiCTR2200061125 (ChiCTR.org.cn).

Oxaliplatin plus S-1 with intraperitoneal paclitaxel for the treatment of Chinese advanced gastric cancer with peritoneal metastases.

BACKGROUND: In this study, we tried to access the efficacy and safety of oxaliplatin plus S-1 with intraperitoneal paclitaxel (PTX) for the treatment of Chinese advanced gastric cancer with peritoneal metastases. PATIENTS AND METHODS: Thirty patients diagnosed with advanced gastric cancer underwent laparoscopic exploration and were enrolled when macroscopic disseminated metastases (P1) were confirmed. PTX was diluted in 1 l of normal saline and IP administered through peritoneal port at an initial dose of 40 mg/m2 over 1 h on day1,8, respectively. Oxaliplatin was administered intravenously at an initial dose of 100 mg/m2 on day1, and S-1 was administered orally at an initial dose of 80 mg/m2 for 14 days followed by 7 days rest, repeated by every 3 weeks. RESULTS: Of all these 30 patients, the median number of cycles was 6 (range 2-16) due to the limitation of hematotoxicity and peripheral neuropathy by oxaliplatin. There were 11 (36.7%) patients received conversion surgery. The median progression free survival (PFS) was 6.6 months (95% CI = 4.7-8.5 months) and the median overall survival (OS) was 15.1 months (95% CI = 12.4-17.8 months). The grade 3-4 hematological toxicities were leucopenia (23.3%), neutropenia (23.3%), anemia (16.7%), and thrombocytopenia (20%), respectively. The grade 3-4 non-hematological toxicities were tolerated, most of which were peripheral sensory neuropathy (40%) due to oxaliplatin, diarrhea (20%), nausea and vomiting (26.7%). CONCLUSIONS: SOX+ip PTX regimen was effective in advanced gastric cancer with peritoneal metastasis. Survival time was significantly prolonged by conversion surgery. Grade 3-4 toxicities were uncommon. Large scale clinical trial is necessary to get more evidence to identify its efficacy. TRAIL REGISTRATION: ChiCTR, ChiCTR-IIR-16009802 . Registered 9 November 2016.

Is D2 Lymphadenectomy Alone Suitable for Gastric Cancer With Bulky N2 and/or Para-Aortic Lymph Node Metastases After Preoperative Chemotherapy?

BACKGROUND: For gastric cancer (GC) with extensive lymph node metastasis (bulky N2 and/or para-aortic lymph node metastases), there is no standard therapy worldwide. In Japan, preoperative chemotherapy (PCT) followed by D2 gastrectomy plus para-aortic lymph node dissection (PAND) is considered the standard treatment for these patients. However, in China, the standard operation for GC patients with only bulky N2 metastases was D2 gastrectomy. Besides, after PCT, whether doing PAND improves survival or not is debatable for GC patients with para-aortic lymph node (PAN) metastases. Therefore, we conducted this study to investigate whether D2 lymphadenectomy alone is suitable for these patients after PCT. METHODS: We retrospectively collected data on patients from our electronic medical record system. GC patients with bulky N2 and/or PAN metastases who underwent D2 lymphadenectomy alone after PCT were enrolled. The survival outcomes and chemotherapy responses were analyzed and compared with the results of the JCOG0405 study. RESULTS: From May 2009 to December 2017, a total of 83 patients met all eligibility criteria and were enrolled. The median survival duration for all patients was 40.0 months. The 3-year and 5-year OS rates for all patients were 50.3% and 45.6%, respectively. For patients with only bulky N2 metastasis, the 3-year and 5-year OS rates were 77.1% and 71.6%, respectively, which were similar to the results of the JCOG0405 study (82.7% and 73.4%). For patients with only PAN metastases, the 3-year and 5-year OS rates were 50.0% and 50.0%, respectively, which seemed to be lower than those of the JCOG0405 study (64.3% and 57.1%). For patients with bulky N2 and PAN metastases, the 3-year and 5-year OS rates were 7.4% and 0.0%, respectively, which were lower than those of the JCOG0405 study (20.0% and 20.0%). CONCLUSION: The results of our study suggest that D2 lymphadenectomy alone is suitable for GC patients with only bulky N2 metastasis after PCT. However, D2 lymphadenectomy alone perhaps is not suitable for patients with bulky N2 and PAN metastases after PCT.

Neoadjuvant Chemotherapy Versus Direct Surgery for Locally Advanced Gastric Cancer With Serosal Invasion (cT4NxM0): A Propensity Score-Matched Analysis.

BACKGROUND: For locally advanced gastric cancer (LAGC) with serosal invasion (cT4NxM0), adjuvant chemotherapy (AC) after D2 gastrectomy is the standard therapy in Asia. However, perioperative chemotherapy (PCT) combined with D2 gastrectomy is mostly suggested in Europe and America. As a part of PCT, the value of neoadjuvant chemotherapy (NAC) is unclear. We investigated whether NAC could further improve survival and other outcomes for these patients. METHODS: Patients with cT4NxM0 gastric cancer who underwent D2 gastrectomy were analyzed. The patients were divided into two groups based on whether they received NAC: the neoadjuvant chemotherapy (NAC) and direct surgery (S) groups. After propensity score matching (1:1 ratio), survival and perioperative outcomes were analyzed between the two groups. RESULTS: A total of 902 patients met all the eligibility criteria and were enrolled. After propensity score matching, 221 matched pairs of patients were identified. The median overall survival (OS) and disease-free survival (DFS) of all patients were 75.10 and 43.67 months, respectively. The median OS of patients in the NAC and S groups were undefined and 29.80 months, respectively (P<0.0001). The median DFS of patients in the NAC and S groups were undefined and 22.60 months (P<0.0001). There were no significant differences in the radical degrees of operation between the two groups (P=0.07). However, there were significant differences in postoperative hospital stay (P<0.001) and complications (P=0.037) between the two groups. CONCLUSION: This study suggested NAC can further improve prognosis and prevent recurrence in LAGC (cT4NxM0) patients. NAC is feasible and safe for LAGC (cT4NxM0) patients, and does not increase the risk of perioperative surgery.

Association of preoperative pain catastrophizing with postoperative pain after lower limb trauma surgery.

OBJECTIVES: To evaluate an association between preoperative Nepali pain catastrophizing scale (N-PCS) scores and postoperative pain intensity and total opioid consumption. METHODS: In this prospective cohort study we enrolled 135 patients with an American Society of Anaesthesiologists physical status I or II, aged between 18 and 65 years, and scheduled for surgery for lower-extremity fracture under spinal anaesthesia. Maximum postoperative pain reported during the 24 h was classified into two groups, no-mild pain group (Numeric rating scale [NRS] scores 1-3) and a moderate-severe pain group (NRS 4-10). The Pearson's correlation coefficient was used to compare the association between the baseline N-PCS scores and outcome variables, i.e., the maximum NRS pain score and the total tramadol consumption within the first 24 h after surgery. Logistic regression models were used to identify the predictors for the intensity of postoperative pain. RESULTS: As four patients violated the protocol, the data of 131 patients were analyzed. Mean N-PCS scores reported by the moderate-severe pain group was 27.39 ± 9.50 compared to 18.64 ± 10 mean N-PCS scores by the no-mild pain group (p < 0.001). Preoperative PCS scores correlated positively with postoperative pain intensity (r = 0.43, [95% CI 0.28-0.56], p < 0.001) and total tramadol consumption (r = 0.36, [95% CI 0.20-0.50], p < 0.001). Preoperative pain catastrophizing was associated with postoperative moderate-severe pain (odds ratio, 1.08 [95% confidence interval, 1.02-1.15], p = 0.006) after adjusting for gender, ethnicity and preoperative anxiety. CONCLUSION: Patients who reported higher pain catastrophizing preoperatively were at increased risk of experiencing moderate-severe postoperative pain. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov Identifier: NCT03758560.

Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial.

OBJECTIVES: This study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery. DESIGN: Prospective, randomised, double-blind. SETTING: Tertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, Nepal PARTICIPANTS: 80 patients undergoing non-elective caesarean section with spinal anaesthesia. INTERVENTIONS: Patients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral. RESULTS: The median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0-4.67) mg in ketamine group and 1 (0-6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1-12) hours and 2 (0.5-6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups. CONCLUSIONS: Intravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery. TRIAL REGISTRATION NUMBER: NCT03450499.

A randomized controlled trial to evaluate omentum-preserving gastrectomy for patients with T1-T3 gastric cancer.

Although complete omentectomy is traditionally performed in patients with gastric cancer as part of radical gastrectomy to ensure the elimination of micrometastases, the prognostic value of omentectomy during gastrectomy remains unclear. Retrospective studies have shown that the incidence of metastases in the greater omentum is very low in T1-T3 gastric cancer. Thus radical gastrectomy with D2 lymphadenectomy and preservation of the greater omentum may be a proper curative treatment for gastric cancer patients with T1-T3 tumors. The aim of this article is to describe the design and rationale for this prospective, randomized controlled DRAGON-05 trial, conducted to evaluate the prognostic value of omentum-preserving gastrectomy for patients with T1-T3 gastric cancer. Clinical trial registration: ChiCTR2000040045 (ClinicalTrials.gov).

Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer.

Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer.

The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial.

BACKGROUND: As a component of multimodal analgesia, the administration of systemic lidocaine is a well-known technique. We aimed to evaluate the efficacy of lidocaine infusion on postoperative pain-related outcomes in patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty. METHODS: In this randomized controlled double-blind study, we recruited 64 patients to receive either lidocaine 2% (intravenous bolus 1.5 mg. kg - 1 followed by an infusion of 2 mg. kg- 1. h- 1), or an equal volume of normal saline. The infusion was initiated just before the induction of anesthesia and discontinued after tracheal extubation. The primary outcome of the study was postoperative morphine equivalent consumption up to 24 h after surgery. Secondary outcomes included postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain. RESULTS: The median (IQR) cumulative postoperative morphine equivalent consumption in the first 24 h was 0 (0-1) mg in the lidocaine group and 4 [1-8] mg in the saline group (p < 0.001). Postoperative pain intensity at rest and during movement at various time points in the first 24 h were significantly lower in the lidocaine group compared with the saline group (p < 0.05). Fewer patients reported PONV in the lidocaine group than in the saline group (p < 0.05). Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001). Patients receiving lidocaine were more satisfied with postoperative analgesia than those receiving saline (p = 0.02). No difference was detected in terms of postoperative sedation and chronic pain after surgery. CONCLUSIONS: Intraoperative lidocaine infusion for laparoscopic TEP inguinal hernioplasty reduces opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov- NCT02601651. Date of registration: November 10, 2015.

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial.

BACKGROUND: The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a single-arm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma. METHODS: Treatment-naïve patients received three preoperative cycles of S-1 (80-120 mg/day on days 1-14) and oxaliplatin (130 mg/m2 on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061. RESULTS: Of 29 patients included, median age was 60 (range, 43-73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%-97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3%-92.0%) and a disease control rate of 96.6% (95% CI, 82.2%-99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2%-26.3%). Downstaging of overall TNM stage was observed in 16 (55.2%) patients. During neoadjuvant therapy, 10 (34.5%) patients had grade ≥III adverse events. No treatment-related death occurred. Surgery-related complications were observed in 12 of 28 (42.9%) patients. CONCLUSION: SOXA followed by surgery in patients with locally advanced gastric adenocarcinoma showed favourable activity and manageable safety. A randomised controlled trial in locally advanced gastric or oesophagogastric junction adenocarcinoma is ongoing (ClinicalTrials.gov: NCT04208347).

Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China.

BACKGROUND: Neoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries. We conducted a prospective study on the safety and feasibility of the FLOT regimen in Chinese patients. METHODS: Patients with adenocarcinoma of the stomach or esophagogastric junction received four cycles of neoadjuvant chemotherapy (NAC) and four cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities, and pathological tumor regression were analyzed. The 2-year overall survival (OS) and relapse-free survival are presented. RESULTS: Altogether, 10 patients were enrolled, and all patients completed four cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and three patients had complete or subtotal pathological tumor regression. Nine patients completed four cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, eight patients achieved the overall survival endpoint, and seven patients had relapse-free survival for this period. Two patients died of disease progression. CONCLUSIONS: Our study demonstrates that the neoadjuvant FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort. The trial is registered with ClinicalTrials.gov (number NCT03646591).

Overexpression of CrkL as a novel biomarker for poor prognosis in gastric cancer.

BACKGROUND: The signaling adapter protein CrkL plays vital roles in multiple cancers. However, the expression pattern of CrkL protein and its clinical significance have not been well characterized in human gastric cancer (GC) so far. OBJECTIVE: To investigate the association of tissue-based CrkL protein expression level with the clinicopathological characteristics and prognosis of GC patients. METHODS: The expression level of CrkL protein in 380 GC patients was analyzed by immunohistochemistry. The associations of CrkL protein expression level with clinicopathologicalal characteristics and clinical outcome were evaluated. RESULTS: Compared with the matched adjacent non-tumor tissues, CrkL protein expression level was significantly up-regulated in tumor tissues. In addition, there was a positive correlation between CrkL and Ki67 expression levels in GC patients. An elevated CrkL level statistically correlated with aggressive clinicopathologicalal characteristics, such as larger tumor size, deeper local invasion, more lymph node metastasis, advanced TNM stage, and poorer prognosis. Notably, multivariate analysis identified tissue-based CrkL level as an independent predictor for the unfavorable prognosis of GC. CONCLUSIONS: These results indicate that CrkL protein may serve as a novel prognostic biomarker in GC.

Postoperative Visual Loss Following Spine Surgery: A Case Report.

Postoperative visual loss is a rare but devastating complication of non-ophthalmic surgery. Its aetiology is poorly understood and multiple associated factors have been proposed. We present a report of a 33-year-old female who developed irreversible diminution of vision on the right eye (non-arteritic-posterior-ischemic-optic-neuropathy) following general anaesthesia for pedicle screw fixation and plating for fracture vertebrae and hip in prone position and then screw placement for fracture calcaneum in supine position. The vision loss, limited to finger count close to face on the right eye, did not improve till follow-up at one-year. The combination of mild intraoperative hypotension, anaemia, prone positioning, prolonged surgery and anaesthesia may have contributed to postoperative visual loss in our patient. Keywords: ischaemic optic neuropathy; postoperative visual loss; spine surgery.