Chinese Study Group Research Articles

Exploratory study of an anti-PD-L1/TGF-β antibody, TQB2858, in patients with refractory or recurrent osteosarcoma and alveolar soft part sarcoma: a report from Chinese sarcoma study group (TQB2858-Ib-02)

Background Novel and effective immunotherapies are required for refractory or recurrent sarcomas. Transforming growth factor-beta (TGF-β) is a diverse regulatory and fibrogenic protein expressed in multiple sarcoma tumors that promotes epithelial-mesenchymal transition and excessive deposition of extracellular matrix. This study evaluated the efficacy and safety of the anti-PD-L1/TGF-β antibody TQB2858 in patients with refractory osteosarcoma and alveolar soft part sarcoma (ASPS).MethodsThis single-arm phase 1b exploratory study included patients with refractory osteosarcoma or ASPS who had previously undergone at least two lines of systemic therapy. Patients were administered 1200 mg of TQB2858 once every 3 weeks. The primary endpoint was objective response rate (ORR), with null and alternative hypotheses of ORR ≤5% and ≥20%, respectively. Exploratory biomarker analyses using immunohistochemistry (IHC) staining (for PD-L1 and TGF-β) were performed on pre-treatment tumor samples.ResultsEleven eligible patients were included in this study. TQB2858 did not demonstrate evidence of efficacy as 0/5 osteosarcomas had any objective response, while 2/6 ASPS showed a partial response. The median progression-free survivals were 1.51 (1.38, Not Evaluable) and 2.86 (1.38, Not Evaluable) months for the osteosarcoma and ASPS groups, respectively. None of the administered cycles met the criteria for unacceptable toxicity. Other Grade 3 toxicities included abnormal liver function and elevation of γ-glutamyl transferase. IHC analysis revealed that functional enrichment in the TGF-β pathway or PD-L1 was not associated with treatment outcomes.ConclusionsThe combination of PD-L1 and TQB2858 did not significantly improve the ORR in patients with recurrent osteosarcoma. However, it improved immunogenic responses in ASPS, even after progression upon anti-PD-1/PD-L1 therapy, with an acceptable safety profile. IHC profiling with pathway enrichment analysis may not have any predictive value for survival outcomes.Trial registrationProspectively registered in the Ethical Review Committee of Peking University People’s Hospital. The trial registration number is 2021PHA105-001 and 2021PHA140-001 and the registration date was March 2, 2022.ClinicalTrials.gov Identifier CTR20213001 and CTR20220390

Radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS) for resectable body and tail pancreatic adenocarcinoma: protocol of a multicenter, prospective, randomized phase III control trial (CSPAC-3)

BackgroundPancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy. Radical surgical resection offers the only potential cure. There is increasing agreement that radical antegrade modular pancreatosplenectomy (RAMPS) may benefit patients with tumors in the body and tail of the pancreas. To address this, the Chinese Study Group for Pancreatic Cancer (CSPAC)-3 trial is proposed to compare the effect of RAMPS and standard retrograde pancreatosplenectomy (SRPS) on patient survival and preoperative safetyMethodsThe randomized controlled trial will be multicenter and two-armed with blinded outcomes and intention-to-treat analysis. Three hundred patients with resectable body and tail pancreatic adenocarcinoma will be enrolled and randomly assigned to RAMPS or SRPS. Adjuvant chemotherapy based on an initial regimen will be recommended 4–6 weeks after surgery if no serious complication occurs. The hypothesis that RAMPS improves survival outcomes compared with SRPS will be tested using a superiority trial. The primary outcome will be overall survival (OS). Secondary outcomes will include recurrence-free survival (RFS), R0 resection rate, the number of harvested lymph nodes, postoperative complications, and quality of life scores.DiscussionThe use of RAMPS has increased over the past decade. It is reported that RAMPS is superior to SRPS in improving both the rate of R0 resection and lymph node yield. Despite these advantages, however, there is little high-level documentation of the superiority of RAMPS in terms of survival and this needs to be investigated. To address this issue, CSPAC has instigated the first prospective, randomized phase III control trials, aiming to explore the optimal surgical strategy for improving the prognosis and OS of patients with left-sided pancreatic cancerTrial registrationChinese Clinical Trial Registry ChiCTR2100053844; pre-results. Registered on December 1, 2021.

The relation between radiographic manifestation and clinical characteristics of congenital radioulnar synostosis in children: A retrospective study from multiple centers.

To review the radiographic manifestation and clinical appearance of children with congenital radioulnar synostosis (CRUS) retrospectively. Retrospective cohort study of children with CRUS from multiple medical centers. A total of 329 patients (male 259, female 70) with an average age of 5.4 years (0.5-16 years old), were included in this study. In particular, 145 patients (145/329, 44.1%) demonstrated bilateral involvement, and 184 patients (left 123, right 61) demonstrated unilateral involvement. As for Clear and Omery (C&O) classification, most patients belonged to Type III, and then followed by Type IV. As for Chinese Multi-center Pediatric Orthopedic Study Group (CMPOS) classification, most patients belonged to Type III, and then followed by Type II and Type I. In C&O Type III, 92.03% patients demonstrated severe pronation. According to CMPOS classification, 92.98% Type I patients demonstrated neutral to mild pronation, 72.17% Type II patients demonstrated moderate pronation, and 92.03% Type III patients demonstrated severe pronation. The age distribution showed no significant difference between C&O Type II and IV (P = 0.96); the pronation ankylosis severity showed no significant difference between C&O Type II and IV (P = 0.387). Although CRUS is a rare forearm deformity, there are certain relation between radiographic manifestation and clinical forearm functional restriction. CRUS patients of C&O or CMPOS Type III classification might suffer severe pronation deformity and warrant early intervention.

The consensus of Chinese experts on the application of percutaneous endoscopic lumbar interbody fusion

Recently, the percutaneous endoscopic lumbar interbody fusion (PELIF) technique has become the most representative minimally invasive technique in spinal surgery. PELIF is widely used in the treatment of various degenerative diseases of the lumbar spine. However, this technique has a long learning curve with adverse consequences for the patient if the surgeon is unsure of the indications and contraindications of this technique. There is currently no expert consensus on PELIF in spinal surgery in China. To standardize the application of this technique in various diseases of the lumbar spine in China, the Chinese Study Group of Minimal Invasive Spinal Surgery, Chinese Association of Spine and Spinal Cord, and Chinese Study Group for Lumbar Spine, Chinese Association of Spine and Spinal Cord, of the Chinese Association of Rehabilitation Medicine have taken the lead in developing this Chinese expert consensus on the application PELIF through a modified Delphi survey study method for the reference of our colleagues. The consensus covers the following aspects of the PELIF: indications and contraindications, advantages and disadvantages, preoperative evaluation, anesthesia methods and surgical procedures, treatment and prevention of complications, and postoperative follow-up.

Expert Consensus on Clinical Application of Lateral Lumbar Interbody Fusion: Results From a Modified Delphi Study.

Modified Delphi study. The objective of this study was to establish expert consensus on the application of lateral lumbar interbody fusion (LLIF) by using the modified Delphi study. From June 2019 to March 2020, Members of the Chinese Study Group for Lateral Lumbar Spine Surgery were selected to collect expert feedback using the modified Delphi method where 65 spine surgeons from all over China agreed to participate. Four rounds were performed: 1 face-to-face meeting and 3 subsequent survey rounds. The consensus was achieved with ≥a 70.0% agreement for each question. The recommendation of grade A was defined as ≥90.0% of the agreement for each question. The recommendation of grade B was defined as 80.0-89.9% of the agreement for each question. The recommendation of grade C was defined as 70.0-79.9% of the agreement for each question. A total of 65 experts formed a panelist group, and the number of questionnaires collected was 63, 59, and 62 in the 3 rounds. In total, 5 sections, 71 questions, and 382 items achieved consensus after the Delphi rounds including summary; preoperative evaluation; application at the lumbar spinal stenosis, lumbar disc herniation, lumbar spondylolisthesis, adult degenerative scoliosis, postoperative adjacent segmental degeneration, and revision surgery; complications; and postoperative follow-up evaluation of LLIF. The modified Delphi method was utilized to ascertain an expert consensus from the Chinese Study Group for Lateral Lumbar Spine Surgery to inform clinical decision-making in the application of LLIF. The salient grade A recommendations of the survey are enumerated.

Simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis: protocol of a multicentre, prospective, randomised phase III control trial (CSPAC-1)

IntroductionApproximately 50% of pancreatic ductal adenocarcinoma (PDAC) patients are diagnosed with distant metastasis, especially liver metastasis. The current standard treatment for these stage IV patients is palliative chemotherapy. There is...

Complications constitute a major risk factor for mortality in hepatitis B virus-related acute-on-chronic liver failure patients: a multi-national study from the Asia-Pacific region.

Cirrhosis is a controversial determinant of mortality in HBV-related acute-on-chronic liver failure (HBV-ACLF). The present study aimed to explore the effects of cirrhosis and the associated risk factors, especially its complications, on the outcome of HBV-ACLF. A prospective-retrospective cohort of 985 patients was identified from the APASL-ACLF Research Consortium (AARC) database and the Chinese Study Group. Complications of ACLF (ascites, infection, hepatorenal syndrome, hepatic encephalopathy, upper gastrointestinal bleeding) as well as cirrhosis and the current main prognostic models were measured for their predictive ability for 28- or 90-day mortality. A total of 709 patients with HBV-ACLF as defined by the AARC criteria were enrolled. Among these HBV-ACLF patients, the cirrhotic group showed significantly higher mortality and complications than the non-cirrhotic group. A total of 36.1% and 40.1% of patients met the European Association for the Study of Liver (EASL)-Chronic Liver Failure consortium (CLIF-C) criteria in the non-cirrhotic and cirrhotic groups, respectively; these patients had significantly higher rates of mortality and complications than those who did not satisfy the CLIF-C criteria. Furthermore, among patients who did not meet the CLIF-C criteria, the cirrhotic group exhibited higher mortality and complication rates than the non-cirrhotic group, without significant differences in organ failure. The Tongji prognostic predictor model score (TPPMs), which set the number of complications as one of the determinants, showed comparable or superior ability to the Chinese Group on the Study of Severe Hepatitis B-ACLF score (COSSH-ACLFs), APASL-ACLF Research Consortium score (AARC-ACLFs), CLIF-C organ failure score (CLIF-C OFs), CLIF-C-ACLF score (CLIF-C-ACLFs), Model for End-Stage Liver Disease score (MELDs) and MELD-sodium score (MELD-Nas) in HBV-ACLF patients, especially in cirrhotic HBV--ACLF patients. Patients with two (OR 4.70, 1.88) or three (OR 8.27, 2.65) complications had a significantly higher risk of 28- or 90-day mortality, respectively. The presence of complications is a major risk factor for mortality in HBV-ACLF patients. TPPM possesses high predictive ability in HBV-ACLF patients, especially in cirrhotic HBV-ACLF patients.

828TiP - Simultaneous resection of pancreatic cancer and liver oligometastases after induction chemotherapy in stage IV patients: An open-label prospective randomized multicenter phase III trial (CSPAC-1)

BackgroundApproximately 40% pancreatic ductal adenocarcinoma (PDAC) patients (pts) are diagnosed with distant metastasis, especially liver metastasis. The current standard treatment for these Stage IV pts is palliative chemotherapy. However, the improved safety of pancreatic surgery has led to the consideration of more aggressive approaches. There is increasing agreement that the synchronous resection of PDAC and liver metastases may benefit highly selected pts. Thus, CSPAC-1 trial to evaluate a treatment strategy for selecting pts who can benefit from the synchronous resection after induction chemotherapy is launched by Chinese Study Group for Pancreatic Cancer (CSPAC). Trial designLiver oligometastases is defined as no more than 3 metastatic lesions irrespective of distribution within liver lobes. The study contains two steps. In the first step, 1000∼1200 cases of stage IV PDAC pts 18∼75 yo who had pathologically confirmed via needle biopsy from hepatic oligometastases or pancreatic lesions, ECOG 0∼1 are eligible for inclusion. Candidates will receive standard first-line chemotherapy including standard or modified FOLFIRINOX (5-FU, leucovorin, irinotecan, oxaliplatin), NG (nab-paclitaxel plus gemcitabine) or GS (gemcitabine plus S-1). RECIST v1.1 criteria combining with tumor markers would be applied to evaluate tumor response to chemotherapy every two cycles. Approximately 30% surgical conversion rate after induction chemotherapy can be achieved according to our prior small sample study. 300 pts who meet the criteria for intervention will get access to the second step and be randomly assigned in a 1:1 ratio to simultaneous resection of primary PDAC and liver oligometastases or standard chemotherapy. The primary outcome of this clinical trial is real overall survival (from enrollment to death). Main secondary outcome measures including overall survival (from randomization to death), life quality score, postoperative morbidity, and mortality. This study was activated in July 2018 and is expected to complete accrual within 5 years. Clinical trial identificationNCT03398291. Legal entity responsible for the studyThe Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd. FundingThe Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd. DisclosureAll authors have declared no conflicts of interest.

BRCA mutation frequency and clinical features of ovarian cancer patients: A report from a Chinese study group.

Subjects with germline BRCA1/2 mutations (gBRCAm) have an increased risk of developing breast cancer and ovarian cancer. At present, knowledge of BRCA1/2 mutation frequency in Chinese patients with ovarian cancer is still insufficient, and the detailed clinical information of these patients is poorly understood. A total of 547 unselected ovarian cancer patients were enrolled, and their gBRCAm status was detected. Clinical characteristics including age, personal and family history, histopathologic diagnosis, carbohydrate antigen 125 (CA-125) level, ascites, Federation International of Gynecology and Obstetrics (FIGO) stage, residual lesions, platinum sensitivity, recurrence interval and survival information were collected. Accurate assessments of disease response were based on the RECIST standard or CA-125 level. In 547 patients with ovarian cancer, we detected 129 (23.6%) patients with pathogenic mutations, 84 patients with BRCA1 mutations (15.4%) and 45 patients with BRCA2 mutations (8.2%). Twenty-five novel mutations were identified, and the mutation of BRCA1, c.5470_5477del8, was the most common mutation in this study. BRCA1/2 mutations were significantly associated with age; personal and family history; FIGO stage; secondary recurrence interval; sensitivity to platinum in 1st, 2nd and 3rd line treatment; and response to doxorubicin liposomes. Patients with BRCA1/2 mutations showed significant advantages in 3- and 5-year survival rates but no advantage in long-term survival. BRCA1/2 mutation prevalence in Chinese ovarian cancer patients is higher than the international rate. We recommend BRCA1/2 testing for patients with family histories and personal histories of malignancy and genetic counseling for cancer in healthy people with high-risk family histories.

Experts consensus on the management of delirium in critically ill patients

To establish the experts consensus on the management of delirium in critically ill patients. A special committee was set up by 15 experts from the Chinese Critical Hypothermia-Sedation Therapy Study Group. Each statement was assessed based on the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) principle. Then the Delphi method was adopted by 36 experts to reassess all the statements. (1) Delirium is not only a mental change, but also a clinical syndrome with multiple pathophysiological changes. (2) Delirium is a form of disturbance of consciousness and a manifestation of abnormal brain function. (3) Pain is a common cause of delirium in critically ill patients. Analgesia can reduce the occurrence and development of delirium. (4) Anxiety or depression are important factors for delirium in critically ill patients. (5) The correlation between sedative and analgesic drugs and delirium is uncertain. (6) Pay attention to the relationship between delirium and withdrawal reactions. (7) Pay attention to the relationship between delirium and drug dependence/withdrawal reactions. (8) Sleep disruption can induce delirium. (9) We should be vigilant against potential risk factors for persistent or recurrent delirium. (10) Critically illness related delirium can affect the diagnosis and treatment of primary diseases, and can also be alleviated with the improvement of primary diseases. (11) Acute change of consciousness and attention deficit are necessary for delirium diagnosis. (12) The combined assessment of confusion assessment method for the intensive care unit and intensive care delirium screening checklist can improve the sensitivity of delirium, especially subclinical delirium. (13) Early identification and intervention of subclinical delirium can reduce its risk of clinical delirium. (14) Daily assessment is helpful for early detection of delirium. (15) Hopoactive delirium and mixed delirium are common and should be emphasized. (16) Delirium may be accompanied by changes in electroencephalogram. Bedside electroencephalogram monitoring should be used in the ICU if conditions warrant. (17) Pay attention to differential diagnosis of delirium and dementia/depression. (18) Pay attention to the role of rapid delirium screening method in delirium management. (19) Assessment of the severity of delirium is an essential part of the diagnosis of delirium. (20) The key to the management of delirium is etiological treatment. (21) Improving environmental factors and making patient comfort can help reduce delirium. (22) Early exercise can reduce the incidence of delirium and shorten the duration of delirium. (23) Communication with patients should be emphasized and strengthened. Family members participation can help reduce the incidence of delirium and promote the recovery of delirium. (24) Pay attention to the role of sleep management in the prevention and treatment of delirium. (25) Dexmedetomidine can shorten the duration of hyperactive delirium or prevent delirium. (26) When using antipsychotics to treat delirium, we should be alert to its effect on the heart rhythm. (27) Delirium management should pay attention to brain functional exercise. (28) Compared with non-critically illness related delirium, the relief of critically illness related delirium will not accomplished at one stroke. (29) Multiple management strategies such as ABCDEF, eCASH and ESCAPE are helpful to prevent and treat delirium and improve the prognosis of critically ill patients. (30) Shortening the duration of delirium can reduce the occurrence of long-term cognitive impairment. (31) Multidisciplinary cooperation and continuous quality improvement can improve delirium management. Consensus can promote delirium management in critically ill patients, optimize analgesia and sedation therapy, and even affect prognosis.

Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02\u201301 multicenter randomized controlled clinical trial

BackgroundThe safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02–01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG).MethodsThis CLASS02–01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n = 100) and OTG group (n = 100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.DiscussionThis CLASS02–01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer.Trial registrationClinicalTrials.gov ID: NCT03007550. December 30, 2016.

Risk factors associated with early postoperative complications following laparoscopic total gastrectomy: Experience from the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) group.

e15544 Background: The incidence rate of proximal gastric cancer has been rising steadily, and laparoscopic total gastrectomy (LTG) has been widely adopted. However, the safety of LTG still lacks solid evidence to prove. The aim of this study was to evaluate morbidity and mortality of LTG, and determine the risk factors associated with early postoperative complications. Methods: A retrospective multicenter study was carried out in China, and medical records of 109 gastric cancer patients receiving LTG during September 2014 and June 2016 were retrieved from the database. Patient characteristics, surgical outcomes, and postoperative morbidities and mortalities were analyzed. Results: Morbidity and mortality rates were 22.0% and 0% respectively. Pulmonary infection (13.8%, n = 15) was the most common complication. Most complications were grade II (15.5%, n = 17) according to the Clavien-Dindo classification. Multivariable analysis identified comorbidity, type of reconstruction method (TLTG) were independent risk factors of early postoperative complications. Comorbidity was the only independent risk factor of complications graded more than II. Diabetes mellitus was found correlated with surgical complication in subgroup analysis. Conclusions: LTG is safe and technically feasible in treating gastric cancer. Careful selection of patients without comorbidity and applying laparoscopy-assisted total gastrectomy instead of totally laparoscopic total gastrectomy may decrease postoperative complications.

Progress of CLASS-01 trial of Chinese laparoscopic gastrointestinal surgery study group

The development of gastrointestinal minimally invasive surgery in China is changing during the past decade. The Chinese laparoscopic gastrointestinal surgery study (CLASS) group as the earliest and most closely cooperated organization for surgical clinical researches, under the support of Chinese Medical Association, Chinese Anti-cancer Association and Chinese Medical Doctor Association, the clinical research capacity and minimally invasive technology of the CLASS group continue to be developed. With the launch of the prospective, randomized, controlled CLASS-01 trial for the treatment of locally advanced gastric cancer in 2012 and the publication of safety results of laparoscopic surgery for gastric cancer in 2016, the international academic community is increasingly focusing its attention on China. This article attempts to review the history and development of the CLASS group in the past 7 years, aiming to prospect the future and attempt to create trends. Key words: Gastrointestinal surgery; Clinical research; Laparoscopy

Surgery management for sporadic small (≤2 cm), non-functioning pancreatic neuroendocrine tumors: a consensus statement by the Chinese Study Group for Neuroendocrine Tumors (CSNET).

The incidence of small (≤2cm), non-functioning pancreatic neuroendocrine tumors (NF-pNETs) increased in the last decades. Before making appropriate strategy for patients with NF-pNETs ≤2cm, pathological confirmation is vital. Incidentally diagnosed, sporadic small NF-pNETs may bring aggressive behavior and poor prognosis, such as extrapancreatic extension, lymph nodal metastasis, distant metastasis and recurrence, even causing disease-related death. Understanding and formulating an appropriate strategy for the patients with sporadic small, non-functioning pancreatic neuroendocrine tumors have been controversial for some time. Although several studies have reported that patients with NF-pNETs ≤2cm had less rate of malignant behavior compared with larger ones (>2 cm); and the surgery approach may leading to surgery-related pancreatic complications; but there is still a lack of levelI evidence to convince surgeons to abandon all cases with sporadic small NF-pNETs. Based on an updated literature search and review, the members of the Chinese Study Group for Neuroendocrine Tumors (CSNET) from high-volume centers have reached a consensus on the issue of the management strategy for the sporadic small NF-pNETs. We recommend that, except for some selected patients with NF-pNETs <1cm, incidentally discovered and unacceptable surgical risks, all others with NF-pNETs ≤2cm should undergo tumor resection with lymph node dissection or at least lymph node sampling and careful postoperative surveillance.

Current status of clinical research for laparoscopic gastrectomy of gastric cancer in China

Gastric cancer is ranked the third cause of cancer deaths in China, and gastric cancer patients from China accounts for 42% of new gastric cancer cases worldwide. Yet, more than 80% of diagnosed gastric cancer patients were in the advanced stage partially because of a lack of national screening strategy in China. Laparoscopic gastrectomy of gastric cancer has been becoming popular in the past decades, as with Japan and Korea. Since the safety and efficacy of laparoscopic gastrectomy have not been evaluated by evidence-based medicine, laparo-scopic gastrectomy in the treatment of gastric cancer in the advanced stage remains controversial, and scientific and regorous randomized controlled trial is known as the best way providing conclusive evidence. In this context, China has more responsibility for contribution to gastric cancer research. To fill this gap, the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)group was established to offer more high-quality Chinese data in the evidense-based medicine with the great help of international academic societies like Korean Gastric Cancer Association, Japanese Gastric Cancer Association, Laparoscopic and Endoscopy Group of Surgery Branch of Chinese Medical Association and Gastric Cancer Association of Chinese Anti-Cancer Association. In this review, the current status of clinical research for laparoscopic surgery of gastric cancer in China was summarized. Key words: Gastric neoplasms; Radical gastrecto-my; Laparoscopy; Clinical research

The clinical utility of CA125/MUC16 in pancreatic cancer: A consensus of diagnostic, prognostic and predictive updates by the Chinese Study Group for Pancreatic Cancer (CSPAC).

The prognosis for pancreatic cancer (PC) is poor; however, the timely and accurate treatment of this disease will significantly improve prognosis. Serum biomarkers involve non-invasive tests that facilitate the early detection of tumors, predict outcomes and assess responses to therapy, so that the patient can be continuously monitored and receive the most appropriate therapy. Studies have reported that cancer antigen (CA)125 [also known as mucin 16 (MUC16)] has functional significance in the tumorigenic, metastatic and drug resistant properties of PC. Our aim was to use this biomarker in the diagnosis, detection of metastasis, prognosis and in the monitoring of the treatment effects of PC. Members of the Chinese Study Group for Pancreatic Cancer (CSPAC) reviewed the literature on CA125/MUC16 and developed an objective consensus on the clinical utility of CA125/MUC16 for PC. They confirmed the role of CA125/MUC16 in tumorigenesis and the progression of PC, and recommended monitoring CA125/MUC16 levels in all aspects of the diagnosis and treatment of PC, particularly those that involve the monitoring of treatments. In addition, they suggested that the combination of other biomarkers and imaging techniques, together with CA125/MUC16, would improve the accuracy of the clinical decision-making process, thereby facilitating the optimization of treatment strategies. Periodic clinical updates of the use of CA125/MUC16 have been established, which are important for further analyses and comparisons of clinical results from affiliates and countries, particularly as regards the in-depth biological function and clinical translational research of this biomarker.

Should a standard lymphadenectomy during pancreatoduodenectomy exclude para-aortic lymph nodes for all cases of resectable pancreatic head cancer? A consensus statement by the Chinese Study Group for Pancreatic Cancer (CSPAC).

Understanding and formulating an appropriate strategy for the para-aortic lymph nodes (LN16) during curative surgery for pancreatic head cancer have been controversial for some time. This study intended to provide a recommendation for surgeons to perform an optimal curative surgery on pancreatic cancer patients with or without LN16 involvement. Based on an updated literature search and review, the members of the Chinese Study Group for Pancreatic Cancer (CSPAC) from high-volume centers reached a consensus on the issue of LN16 in pancreatic head cancer. Metastasis to LN16 is quite common in pancreatic head cancer cases. Depending on the location of the tumor, including the ventral and dorsal pancreas, there could be various lymph node drainage pathways whereby LN16 does not necessarily belong to the Group 3 lymph node stations for all cases of pancreatic head cancer. Although LN16 involvement generally indicates a poor prognosis, some cohorts of LN16-involved cases have benefited from a curative surgery, and there is still a lack of level I evidence to convince surgeons to abandon all resectable cases with LN16 positivity. Resection of LN16 combined with a standard lymphadenectomy during pancreatoduodenectomy is recommended by CSPAC, except in patients with both positive LN16 and criteria based on: i) the resectability status of primary tumor; ii) the extent of involved para-aortic lymph nodes; and iii) the serum tumor burden assessed preoperatively.

Laparoscopic D2 subtotal gastrectomy versus conventional open surgery for advanced gastric cancer: The safety analysis from a multicenter prospective randomized controlled trial in China (CLASS-01 trial).

122 Background: The efficacy of laparoscopic D2 gastrectomy for the treatment of advanced gastric cancer (AGC) with curative intent is still controversial. Thus, the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) group conducted a multicenter prospective randomized controlled trial, aiming to evaluate the surgical safety and long-term outcomes of laparoscopic D2 gastrectomy compared with conventional open surgery for AGC. (NCT01609309) Methods: The patients with tumor located at distal stomach at clinical T2-4a, N0-3, M0 stage were eligible for enrollment, treated by either laparoscopic D2 distal subtotal gastrectomy (LG) or open D2 gastrectomy (OG) after randomization. Seventeen institutions currently participated in the study. The morbidity and mortality within postoperative 30 days were compared between the two groups. Results: A total of 607 consecutive eligible patients were randomly assigned to either LG group (n=308) or OG group (n=299) between September 2012 and January 2014. The compliance rates of D2 lymphadenectomy in the LG group and OG group were similar (97.4% vs. 98.3%; P=0.591). Open conversion rate was 4.5%. There was no significant differences between the LG group and OG group in the incidence of intraoperative complication (5.8% vs. 4.3%; P=0.402), postoperative morbidity (18.8% vs. 14.7%; P=0.175), and mortality (0.6% vs. 0; P=0.499). The severity grade pattern was also similar according to the Clavien-Dindo classification (P=0.372). Conclusions: Laparoscopic D2 distal subtotal gastrectomy for AGC could be safely performed by experienced surgeons. Thus, our multicenter prospective study on long-term outcomes can be ongoing. Clinical trial information: NCT01609309.

Review: clinical management of Helicobacter pylori infection in China.

Helicobacter pylori (H.pylori) infection has been associated with gastric disorders. The situation of H.pylori infection in China-where a high prevalence of H.pylori infection, a high incidence of gastric cancer, and widespread resistance to clarithromycin, metronidazole, and levofloxacin exist-is quite different from that in Western countries. In order for Chinese clinicians to better manage H.pylori infection, a Chinese Study Group on H.pylori published four consensus reports regarding the management of H.pylori infection in China between 1999 and 2012. The eradication rate with standard triple therapy was <80% in most areas of China. Bismuth is available in China, and bismuth-containing quadruple therapy has been shown to produce a high eradication rate; thus, bismuth quadruple therapy could be recommended both as an initial and as a rescue therapy in China. There is no advantage of sequential therapy over triple therapy in Chinese patients, but the efficacy of concomitant therapy must be studied further. This review introduces the epidemiology, diagnosis, indicators, and therapies for the eradication of H.pylori in China in recent years.

Menopausal symptoms in an intercultural context: a comparison between German women, Chinese women and migrant Chinese women using the Menopause Rating Scale (MRS II).

What are the differences between the occurrence of menopausal symptoms in German women, migrant Chinese women in Germany and Chinese women in their native country? Can these potential discrepancies be explained by sociocultural differences? What are the differences in menopausal symptoms in connection with the consumption of soya? Cross-sectional study 2005-2008. Survey of three groups of women aged between 45 and 60 years (native German women in Berlin, migrant Chinese women in several German cities, Chinese women in Beijing) with an evaluated set of questionnaires surveying socio-demographic data, use of hormone therapy, migration/acculturation, MRS II and other areas. A total of 2,109 questionnaires were sent out and a 41 % response rate was achieved, although this varied greatly across the three individual study groups. The results of the MRS II factor analysis were almost identical for German women and migrant Chinese women, but there were some differences in content compared to the Chinese study group. Chinese women surveyed in Beijing reported severe symptoms significantly less frequently in all three symptom groups (factors) of MRS II than the German women and the migrant Chinese women, but the values from the German women and migrant Chinese women surveyed are relatively similar. In all three study groups there are no significant differences in the stated severity of the symptoms, regardless of whether soya is consumed frequently or less frequently. The question whether the differences found are solely cultural or migration-related must be examined in further studies. The special experiences and situation in life of migrant women should be taken into particular account by attending physicians during the care and treatment of women in this phase of life.