Perioperative systemic and prophylactic intraperitoneal chemotherapy for type 4/large type 3 gastric cancer: DRAGON-10.

Large type 3 and type 4 gastric cancers (GC) have a significantly poor prognosis, primarily due to their high predisposition for peritoneal dissemination. The application of intraperitoneal chemotherapy has emerged as a viable therapeutic strategy for managing GC patients with peritoneal metastasis. This study is planned to enroll 37 resectable large type 3 or type 4 GC patients. These patients are scheduled to undergo a treatment comprising preoperative chemotherapy with paclitaxel, oxaliplatin and S-1, followed by D2 gastrectomy, and concluding with postoperative treatments that include prophylactic intraperitoneal chemotherapy. The study's primary objective is to evaluate the 3-year peritoneal recurrence rate. Secondary objectives are to assess the 3-year disease-free survival, 3-year overall survival and to monitor the adverse events.Clinical trial registration number: ChiCTR2400083253 (https://www.chictr.org.cn).

Gastric cancer (GC), specifically the large type 3 and type 4 kinds, is a serious health condition that often leads to a very poor chance of survival. This is mainly because these types of cancer easily spread to the lining of the abdomen, a process known as peritoneal dissemination. One way to tackle this issue is through a treatment known as intraperitoneal chemotherapy, which directly targets the abdominal lining to kill cancer cells. In our study, 37 resectable large type 3 and type 4 GC patients will receive a combination of chemotherapy drugs before undergoing surgery to remove the cancer. After surgery, they will receive additional treatment that combines chemotherapy into the abdomen with standard chemotherapy. The main goal of our study is to see if this treatment approach can reduce the chance of cancer returning to the abdominal lining within 3 years. We are also looking at how long patients remain free from cancer, their overall survival after 3 years, and any side effects they may experience from the treatment. This study aims to provide a clearer understanding of how effective this combined treatment is for patients with these aggressive types of GC, with the hope of improving their chances of survival and quality of life.

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).

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.

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).

Clinicopathological and Prognostic Features of Surgical Management in Duodenal Gastrointestinal Stromal Tumors.

BACKGROUND AND OBJECTIVES: The rarity of duodenal gastrointestinal stromal tumors (DGIST) led to only limited data being available on their management and prognosis. We retrospectively analyzed the clinicopathological features, surgical treatments, adjuvant therapy, and prognosis of DGIST. METHODS: Sixty-one patients were identified at diagnosis of primary DGIST from February 2005 to December 2015. One hundred twenty six patients with small intestinal gastrointestinal stromal tutors (GIST) were selected as control groups. Survival analyses were calculated using the Kaplan-Meier method. RESULTS: Three- and five-year recurrence/metastasis-free survival rates of patients with DGIST were similar to those of patients with small intestinal GIST (p > 0.05 for all). Out of 61 cases with DGIST, 45 patients were treated with Limited Resection (LR). Sixteen patients were treated with Pancreaticoduodenectomy (PD). The 3- and 5-year recurrence/metastasis-free survival rates of the PD group and LR group were of no significant difference (p > 0.05 for all). Univariate analysis indicated that factors including surgical approaches, mitotic count, size, and risk grades were significantly associated with recurrence/metastasis-free survival (log-rank test, p < 0.05). Multivariate analysis demonstrated that the mitotic count was independently correlated with a worse recurrence/metastasis-free survival. CONCLUSIONS: Patients with radical resected DGIST had a favourable prognosis, which is similar to that of small intestinal GIST. Both LR and PD were optimal choices for treating DGIST.

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.

Radical gastrectomy with combined splenectomy: unnecessary.

UNLABELLED: BACKROUND/AIMS: To analyze the prognostic value of gastric cancer surgery combined with splenectomy for gastric cancer patients. METHODOLOGY: Retrospective study was performed on 112 patients who underwent radical gastrectomy for upper third, upper and middle third, and entire stomach cancer, 61 patients underwent spleen-preserving modified radical lymphadenectomy (spleen-preservation group), and the remaining 51 patients underwent D2 radical lymphadenectomy with splenectomy (splenectomy group). Postoperative morbidity rate and the 5-year survival rate were compared. RESULTS: There was no significant difference between the spleen-preservation group and splenectomy group in gender, age, tumor size, T stage, N stage and TNM stage. The overall 5-year survival rate was 41.0% in the spleen-preservation group, compared with 39.2% in the splenectomy group (p>0.05). The 5-year survival rate of patients in the spleen-preservation group vs splenectomy group was 100% vs 100.0% for stage I, 66.7% vs 70.0% for stage II, 27.8% vs 26.7% for stage III, and 17.4% vs 5.6%for stage IV, respectively (p>0.05). There was a significant difference (p<0.05) in postoperative morbidity rate (11.5% for spleen-preservation group vs 27.5% in the splenectomy group). CONCLUSION: Lower postoperative morbidity but similar 5-year survival rate was observed in spleen-preserving modified radical lymphadenectomy group compared to D2 radical lymphadenectomy with splenectomy.

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.

Why the postoperative mortality rate of gastric cancer is lower in our center?

BACKGROUND/AIMS: There was obvious disparity in postoperative mortality rate of gastric cancer surgery among different centers. We analyzed the postoperative complications of gastric cancer surgery at a pioneer surgical center in China and discussed the possible reason behind lower postoperative mortality rate at this center. METHODOLOGY: A total of 697 patients of gastric cancer surgery were analyzed. The median age of the patients was 58 years. POSSUM (Physiological and operative severity score for the enumeration of morbidity and mortality) was applied to calculate risk adjusted morbidity rate. RESULTS: About 82 percent patients were discharged uneventfully in less than 15 days after surgery. Overall 159 patients had postoperative complications, majority of complication were mild or moderate, only about 4 percent of patients had severe complications. Postoperative anastomotic leak and mortality rate was 1.3 and 0.3 percent respectively. CONCLUSION: The postoperative complications especially the mortality rate was significantly lower in our center. The clinical and surgical experience may have influenced the surgical outcome; however, a well controlled prospective study is necessary to postulate this assumption. Regardless of the reason behind the disparity in postoperative mortality rate among different centers, it is mandatory to minimize the postoperative mortality rate of oncological disease like gastric cancer.

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).

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.

Effect of surgical work volume on postoperative complication: superiority of specialized center in gastric cancer treatment.

PURPOSE: We investigated the risk factors for early postoperative complications after gastric cancer surgery. MATERIALS AND METHODS: The data from a total of 273 patients with gastric cancer were analyzed by univariate and multivariate analysis. We applied physiological and operative severity score for the enumeration of morbidity and mortality (POSSUM) to compare risk-adjusted surgical outcomes among different surgical units. RESULTS: Among the preoperative variables, patient gender, chronic obstructive pulmonary disease, surgical unit, and intraoperative blood loss were independent risk factors for a higher rate of postoperative complications. There were significant differences in complication rates among different surgical units (P = 0.001). The observed-to-expected morbidity ratio (O-to-E ratio) ranged from 0.81 to 1.63. Units with low surgical work volume had higher complication rates. Postoperative length of stay was significantly shorter (P = 0.000) and the rate of moderate and severe complications was significantly lower (P = 0.001) in specialized unit. CONCLUSIONS: POSSUM is a valid system for risk-adjusted evaluation of surgical outcomes. We conclude that surgical experience and work volume greatly influence the outcome, with overall surgical outcome in specialized centers superior to that in other units. Hence, gastric cancer surgery should be performed in specialized centers. Risk factors identified in this study need further confirmation by a prospective study involving a larger cohort.

Importance of surgical audit: postop complication of gastric cancer surgery among different units.

BACKGROUND/AIMS: Comparative surgical audit is a very important issue in surgical practice. The POSSUM (Physiological and Operative Severity Score for the enumeration of Morbidity and mortality) system has been proposed as the most efficient risk adjusting tool which can be used to compare surgical outcome among different units. POSSUM was applied for risk-adjusted auditing of different units in a single hospital. METHODOLOGY: In total, 357 gastric cancer patients who underwent radical resection or palliative procedures were analyzed retrospectively to evaluate predictive value of POSSUM scoring system and postop morbidity was compared among 5 different units in a single hospital. RESULTS: POSSUM predicted well by correct analysis; the observed to expected morbidity ratio (O:E ratio) was 1.01 for patients overall. But there were significant differences in complication rates among different units, the O: E ratio ranging from 0.7-1.63. CONCLUSIONS: POSSUM is a credible tool for predicting postop morbidity in gastric surgery. It provides risk-adjusted morbidity which can be compared directly. There was surprising difference in surgical outcome among different units of a single hospital, this demands more prospective researches to evaluate surgical outcome of different units. We conclude gastric cancer surgery should be performed in specialized centers.

Homocysteine and the risk of age-related macular degeneration: a systematic review and meta-analysis.

Contrasting results have been reported regarding the associations between plasma total homocysteine (tHcy) and B vitamin levels and age-related macular degeneration (AMD) risk. Thus, we aimed to systematically evaluate these associations. Relevant case control studies in English were identified via a thorough search of the PubMed, Medline, and Embase databases from inception to June 2014. The results were pooled using Review Manager 5.2.1. Eleven studies (including 1072 cases and 1202 controls) were eligible for analysis of tHcy levels; additionally, 3 studies (including 152 cases and 98 controls) were eligible for analysis of folic acid and vitamin B12 levels. The cumulative results demonstrated that the plasma tHcy level among the AMD cases was 2.67 µmol/L (95% confidence interval [CI], 1.60-3.74) higher than that among the controls. In contrast, the vitamin B12 level among the AMD cases was 64.16 pg/mL (95% CI, 19.32-109.00) lower than that among the controls. Subgroup analyses showed that the folic acid level was 1.66 ng/mL (95% CI, 0.10-3.21) lower for the wet type. Together, the results demonstrated that AMD is associated with elevated tHcy levels and decreased vitamin B12 levels. Plasma tHcy may act as a modulator of the risk for AMD based on the current evidence.

Reoperation for early postoperative complications after gastric cancer surgery in a Chinese hospital.

AIM: To investigate the occurrence of postoperative complications of gastric cancer surgery, and analyze the potential causes of reoperation for early postoperative complications. METHODS: A total of 1639 patients who underwent radical or palliative gastrectomies for gastric cancer were included in the study. The study endpoint was the analysis of postoperative complications in inpatients. RESULTS: About 31% of patients had early postoperative complications, and complications of infection occurred most frequently. Intra-abdominal hemorrhage and anastomotic leak were the main causes of reoperation, which accounted for about 2.2%. Mortality was 11.1% in the reoperation group, but was only 0.8% in other patients. The duration of postoperative stay in hospital was significantly longer and the total expenditure was markedly higher in the patients who underwent reoperation (P < 0.001). There was no significant association of any available factors in this study with the high rate of reoperation. CONCLUSION: Reoperation significantly increases the mortality rate and raises the burden of the surgical unit. More prospective studies are required to explore the potential risk factors.

Does testosterone prevent early postoperative complications after gastrointestinal surgery?

AIM: To investigate the role of sex hormones in the early postoperative complications of gastrointestinal diseases. METHODS: A total of 65 patients who underwent operations for gastric and colorectal diseases (mainly malignant diseases) were included in the study. Peripheral venous blood samples were collected at different times for analysis of estradiol, testosterone and progesterone. The only study endpoint was analysis of postoperative complications. RESULTS: Patients of both sexes were uniform but postoperative complication rate was significantly higher in female patients (P = 0.027). There was no significant association of estradiol and progesterone with postoperative complications. Testosterone levels in complicated patients were significantly lower than in uncomplicated patients (P < 0.05). Area under the receiver operating characteristic curve showed that a lower value of testosterone was a predictor for higher complication rate (P < 0.05), and a lower value of testosterone at later times after surgery was a better predictor of complications. CONCLUSION: Patients with low testosterone level were prone to higher postoperative complications, which was evident in both sexes. However, further studies are necessary to support this result.