Nordic Gastric and Esophageal Tumor Study
Cancer of StomachCancer of the Esophagus1 moreThis is a population-based case-control study in all 5 Nordic countries from 1994 onwards. All cases with an esophageal or gastric tumor will be compared with 10 times as many population controls, frequency-matched by age, sex, and calendar year, country. This design offers excellent statistical power, length and completeness of follow-up, quality of data on exposures, outcomes and confounders, and control for confounding. The project will include a specific study entitled "Long-term medication with proton pump inhibitors and risk of gastric cancer", which is summarized here: Research question: Medication with proton pump inhibitors (PPI) (e.g., omeprazole and esomeprazole) is one of the most common long-term therapies globally, prompted by its high anti-acidic efficacy and good short-term safety profile. Gastric cancer is the 3rd leading cause of cancer-related mortality globally, responsible for 770,000 deaths each year. There are clear biological mechanisms linking long-term PPI-use with an increased risk of gastric cancer. However, existing research has not been able to provide a definite answer to whether long-term PPI-use is associated with an increased risk of gastric cancer. The reasons are that the literature is hampered by too short follow-up time to assess cancer development, and also insufficient statistical power, lack of population-based design and confounding. With the availability of nationwide complete medication registries in the Nordic countries, the firsts two starting already in 1994 (Denmark and Finland), we can now, by adding registry data from all Nordic countries together, conduct the first study providing a robust and valid answer to this research question. Overarching aim This project aims to clarify if (and if so to what extent) long-term PPI-therapy influences the risk of developing gastric adenocarcinoma. For validation reasons, we will also examine how long-term use of histamine-2-receptor blockers (H2RB) influences the risk of developing gastric adenocarcinoma. These analyses will validate that the findings are specific for PPIs. H2RB are used for the same indications as PPIs, but with a different biological mechanism. Hypothesis We plan to test the hypothesis that long-term use of PPI (but not H2RB) increases the risk of gastric adenocarcinoma. Prerequisites This will be the first project with all prerequisites to provide conclusive answers to the hypotheses above, i.e.: Long follow-up (up to 28 years) Complete follow-up (by virtue of the nationwide complete Nordic registries) Population-based design (which rules out biased selection of cases or controls) Superior statistical power (all five Nordic countries participate with nationwide data) High-quality data on exposures, outcomes and confounders (thanks to well-maintained and complete nationwide Nordic health data registries) Control for confounding factors (available for all participants, both cases and controls)
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
Stomach NeoplasmsColonic Neoplasms10 morePostoperative delirium(POD)is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms
Metachronous NeoplasmGastric Cancer2 moreThe study is a prospective cohort study to investigate whether aberrant DNA methylation can be useful for the prediction of metachronous recurrence after endoscopic resection of gastric neoplasms (dysplasia or cancer). From 2012 to 2017, 300 patients were prospectively enrolled after endoscopic resection (ER) of gastric dysplasia or early gastric cancer. All lesions were assessed by endoscopy and biopsy before ER. Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was performed for gastric dysplasia and early gastric cancers which met the absolute indication (differentiated adenocarcinoma, intramucosal cancer, lesions < 20 mm, and no endoscopic evidence of ulceration). All lesions were curatively resected; if non-curatively resected, the patients were not enrolled from the study. All subjects, who provided informed consent, were asked to complete a questionnaire under the supervision of a well-trained interviewer. The questionnaire included questions regarding demographic data (age, sex), socioeconomic data (smoking, alcohol, and education), their family history of GC in first-degree relatives, and history of H. pylori eradication therapy. Also, MOS methylation level at baseline was measured from noncancerous gastric mucosae at corpus. When H. pylori was positive by CLOtest or histology at baseline or during the follow-up, eradication therapy was done. To evaluate whether H. pylori was eradicated, 13C-urea breath testing was performed at least 4 weeks after completion of the eradication therapy. All study subjects were closely followed up since recurrent tumors at previous endoscopic resection sites can be easily detected on endoscopy with biopsy and treated during follow-up. Patients with local recurrence underwent further treatments, including repeated ESD, APC, and gastrectomy based on pathology, and patients who refused treatment received supportive care. All patients underwent endoscopy with biopsy within 6 months, then at 12 months after ESD to check for metachronous lesions or local recurrences. After 12 months, endoscopy with biopsy was performed annually. In case of EGCs, abdominal CT scan was performed in the first year and biennially thereafter to detect lymph node or distant metastases. The definition of the completion of the study protocol was 1) endoscopic and/or radiologic follow-up for more than 3 years, or 2) development of metachronous gastric neoplasm (primary outcome: gastric dysplasia or cancer) during the follow-up. Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis.
Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery
Gastric CancerSurgery7 moreGastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. By the invented and adopted energy surgical instruments, surgical procedure is safer and easier than before. The newly surgical instruments reduce the post-operative mortality and morbidity combined easy procedures of surgery. As the most popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar electrocautery were received lots of attention and concern. Some studies have shown some advantage of the two instruments, which were they can facilitate the surgical treatment and make the surgery safer and more effective. Although, some small retrospective sample reports claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node intraoperative complications and even postoperative complications. And Korea small sample randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and surgical duration. However, postoperative complications were with no statistical significance between the two instruments. Cost- effective analysis of the energy instruments is still controversial. Large sample randomized control trail with high quality is needed. By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from North to South in China aims to compare the clinical characteristics and outcomes, when using of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative complications, cost data, and post-operative quality of life.
Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled...
Gastric CancerThis study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence
Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients...
Early Gastric CancerThe purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.
A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With...
Gastric CancerThis prospective, multi-center, non-interventional study will evaluate the efficacy and safety of trastuzumab in routine clinical practice in Chinese participants with gastric or gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants will be enrolled and assigned to the various cohorts according to human epidermal growth factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to physician's decision. Treatment patterns and clinical outcomes in participants with gastric cancer in China will be evaluated. The total study duration is 60 months.
DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma
Gastric CarcinomaGastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In previous multi-center study, we have found that the prevalence of GDNF family receptor alpha 1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and coordinately associated with GC metastasis and the patients' overall survival throughout discovery and testing cohorts in China, Japan and Korea. The present cohort study is to investigate whether methylation of those genes can predict the metastasis and prognosis of GC.
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced...
Advanced Gastric CancerGastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease. The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared. The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric...
Gastric CancerThis observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.