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Gastrointestinal stromal tumour is the most common sarcoma of the intestinal tract. Imatinib mesylate is a small molecule that inhibits activation of the KIT and platelet-derived growth factor receptor α proteins, and is effective in first-line treatment of metastatic gastrointestinal stromal tumour. We postulated that adjuvant treatment with imatinib would improve recurrence-free survival compared with placebo after resection of localised, primary gastrointestinal stromal tumour. We undertook a randomised phase III, double-blind, placebo-controlled, multicentre trial. Eligible patients had complete gross resection of a primary gastrointestinal stromal tumour at least 3 cm in size and positive for the KIT protein by immunohistochemistry. Patients were randomly assigned, by a stratified biased coin design, to imatinib 400 mg (n=359) or to placebo (n=354) daily for 1 year after surgical resection. Patients and investigators were blinded to the treatment group. Patients assigned to placebo were eligible to crossover to imatinib treatment in the event of tumour recurrence. The primary endpoint was recurrence-free survival, and analysis was by intention to treat. Accrual was stopped early because the trial results crossed the interim analysis efficacy boundary for recurrence-free survival. This study is registered with ClinicalTrials.gov, number NCT00041197. All randomised patients were included in the analysis. At median follow-up of 19·7 months (minimum–maximum 0–56·4), 30 (8%) patients in the imatinib group and 70 (20%) in the placebo group had had tumour recurrence or had died. Imatinib significantly improved recurrence-free survival compared with placebo (98% [95% CI 96–100] vs 83% [78–88] at 1 year; hazard ratio [HR] 0·35 [0·22–0·53]; one-sided p<0·0001). Adjuvant imatinib was well tolerated, with the most common serious events being dermatitis (11 [3%] vs 0), abdominal pain (12 [3%] vs six [1%]), and diarrhoea (ten [2%] vs five [1%]) in the imatinib group and hyperglycaemia (two [<1%] vs seven [2%]) in the placebo group. Adjuvant imatinib therapy is safe and seems to improve recurrence-free survival compared with placebo after the resection of primary gastrointestinal stromal tumour. US National Institutes of Health and Novartis Pharmaceuticals.

Background Both submucosal tunneling endoscopic resection (STER) and endoscopic full-thickness resection (EFTR) are effective method for treating gastric gastrointestinal stromal tumors (GISTs); however, little is known about the comparison between STER and EFTR. The aim of the study was to compare the safety and efficacy of STER and EFTR for treating gastric GIST. Methods We retrospectively collected the clinical data about patients with gastric GISTs who received STER or EFTR at our hospital from April 2011 to June 2016. Epidemiological data (gender, age), tumor size, procedure-related parameters, complications, length of stay, cost and follow-up data were compared between STER and EFTR. Results A total of 52 patients were enrolled, and 20 of them received STER, while the other 32 cases received EFTR. There was no significant difference between the two groups in terms of gender, age, concomitant diseases, tumor size, en bloc resection rate, operation time, complications, pathohistological grade of GIST, hospital stay and cost ( P  > 0.05). However, patients who received EFTR had a longer suture time and needed more clips to close the gastric-wall defect (STER vs EFTR, 291.5 ± 68.7 vs 380.6 ± 96.9s and 6.0 ± 1.2 vs 7.6 ± 1.6, P  < 0.05). No recurrence was noted in the STER and EFTR groups during a mean follow-up of 10.9 and 23.8 months, respectively. Conclusions The treatment efficacy between STER and EFTR for treating gastric GISTs was comparable, and a large-scale, randomized study is necessary for a more confirmed conclusion.

Background Laparoscopic resection of gastric GISTs appears technically feasible and associated with favorable outcomes. Tumor size however frequently plays a role in surgical approach with larger tumors tending toward laparotomy, raising concern that favorable outcomes reported for the laparoscopic approach may reflect this selection bias. Materials and Methods From a prospectively collected sarcoma database, 155 primary gastric GIST resections were identified (1998–2009); 40 patients underwent successful laparoscopic resection for non-GE junction GIST and were randomly matched (1:1) by tumor size (±2.0 cm) to patients with open resection. Clinical and pathologic variables and surgical outcomes were associated with surgery type using conditional logistic regression analyses. Results The two surgical approaches were comparable for clinical and pathologic variables. Median operating room (OR) time was similar, although median length of stay postsurgery was lower in the laparoscopic versus open group (4 vs. 7 days, P  = 0.002), as was estimated blood loss (EBL) (25 vs. 100 ml, P  = 0.006). There was no operative mortality, and 30-day morbidity was similar. Oncologic outcomes were also similar with no positive microscopic margins, and 1 recurrence in each group with a median follow-up of 34 months. There were 13 conversions overall, 5 secondary to tumor location at the GE junction or lesser curve. Conclusions When matched for tumor size, laparoscopic resection of primary gastric GISTs ≤8 cm results in shorter hospital stays with similar OR time while maintaining sound oncologic outcomes compared with open resection.

Palliative imatinib treatment has dramatically improved survival in patients with malignant gastrointestinal stromal tumours, particularly in patients with tumours harbouring activating KIT mutations. To evaluate the effectiveness of adjuvant imatinib after radical surgery, a consecutive series of patients with high-risk tumours ( n =23) was compared with historic controls ( n =48) who were treated with surgery alone. The mean follow-up period was over 3 years in both groups. Only 1 out of 23 patients (4%) in the adjuvant treatment group developed recurrent disease compared to 32 out of 48 patients (67%) in the control group. This preliminary study indicates that 1 year of adjuvant treatment with imatinib dramatically improves recurrence-free survival. Confirmation of these findings awaits the results of ongoing randomised studies.

Background Surgery is the first choice for the treatment of gastric gastrointestinal stromal tumors (GISTs). With the development of new instruments and techniques, the popularity of laparoscopic resection of GISTs has increased rapidly. Previous studies on the advantages of laparoscopic resection over open surgery are generally limited by methodology or data capacity. This study evaluated the efficacy of laparoscopic resection and open surgery in gastric GISTs using the propensity score matching (PSM) method. Methods Between January 2005 and December 2017, 1027 patients were diagnosed with primary GIST at our institution. Among them, 548 patients were enrolled in this study. Standard demographic and clinicopathological data were collected from our database. Selection bias was eliminated using the PSM methods. Results After PSM, 256 cases involved in the comparison (128 laparoscopic (LAP) vs. 128 open surgery (OPEN)) were randomly matched (1:1) by age, sex, body mass index, hypertension, diabetes, heart disease, year of surgery, tumor location, tumor size, mitotic rate, and treatment with adjuvant tyrosine kinase inhibitors. The LAP group was superior to the OPEN group in blood loss ( χ 2  = 6.048, P =  0.049), time to first flatus (49.41 ± 7.56 vs. 71.31 ± 4.87 h, P  < 0.001), and hospital stay (10.21 ± 6.05 vs. 12.56 ± 5.43 days, P  = 0.001). No significant differences were seen in either the relapse-free survival or overall survival between the LAP and OPEN groups. In tumors located in favorable locations, the LAP group showed less blood loss ( P  = 0.008) and less multivisceral resection (17.8% vs. 5.5%, P  = 0.02). Conclusions Laparoscopic resection for gastric GISTs is associated with improved surgical outcomes and postoperative courses and comparable oncological outcomes, regardless of favorable or unfavorable tumor location.

Background The role of surgery in the management of patients with advanced gastrointestinal stromal tumors (GIST) in the era of imatinib mesylate (IM) remains debated. We analyzed the outcome of patients with non metastatic locally advanced primary GIST treated with IM within the prospective BFR14 phase III trial. Methods The database of the BFR14 trial was searched for patients with no metastasis at time of inclusion. Patients treated for recurrent disease were excluded. Twenty-five of 434 patients met these criteria. Results Fifteen of 25 patients (60%) had a partial response to IM. Nine of the 25 patients (36%) underwent surgical resection of their primary tumor after a median of 7.3 months of IM treatment (range 3.4-12.0). Per protocol patients received continuous IM treatment in the post resection period, in an adjuvant setting. With a median follow-up of 53.5 months, there was a significant improvement in progression-free survival (PFS) and overall survival (OS) for patients who underwent surgical resection versus those who did not (median not reached vs 23.6 months, p = 0.0318 for PFS and median not reached vs 42.2 months, p = 0.0217 for OS). In the group of patients who underwent resection followed by IM, the 3-year PFS and OS rates were 67% and 89% respectively Conclusions Following neoadjuvant IM for non metastatic locally advanced GIST 9 of 25 patients (36%) were selected for resection of the primary tumor. OS and PFS figures were close to those of localised intermediate or high risk GIST (70% at 5 years) in the subgroup of operated patients, while the outcome of the non-operated subgroup was similar to that of metastatic GIST.

Gastrointestinal stromal tumor (GIST) is the most common sarcoma arising in the gastrointestinal (GI) tract. Imatinib mesylate (imatinib) is efficacious in treating advanced and metastatic GIST. Patients undergoing resection of GIST realize a highly variable median disease-free survival (DFS). In the absence of prospective data, we conducted a randomized, phase II study to assess the safety and efficacy of preoperative and postoperative imatinib for the treatment of GIST. Nineteen GIST patients undergoing surgical resection were randomized to receive 3, 5, or 7 days of preoperative imatinib (600 mg daily). Patients received postoperative imatinib for 2 years. Perioperative adverse events were compared with those in an imatinib-naïve historical control. The efficacy of imatinib was assessed by 18 fluorodeoxyglucose positron emission tomography ( 18 FDG-PET), dynamic computed tomography (dCT), terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, and DFS. Imatinib did not affect surgical morbidity as compared with an imatinib-naïve cohort ( p  ≥ 0.1). Most patients responded to preoperative imatinib by 18 FDG-PET and dCT (69% and 71%, respectively). Tumor cell apoptosis increased by an average of 12% (range 0–33%) and correlated with the duration of preoperative imatinib ( p  = 0.04). Median DFS of patients treated with surgery and imatinib was 46 months (range 10–46 months). Tumor size was a predictor of recurrence after postoperative imatinib ( p  = 0.02). Imatinib appears to be safe and may be considered for patients undergoing surgical resection of their GIST. Radiographic response and tumor cell apoptosis occur within the first week of imatinib therapy.

Introduction Gastrointestinal stromal tumor (GIST) is the most common gastrointestinal soft tissue tumor. Clinical diagnosis mainly relies on enhanced CT, endoscopy and endoscopic ultrasound (EUS), but the misdiagnosis rate is still high without fine needle aspiration biopsy. We aim to develop a novel diagnostic model by analyzing the preoperative data of the patients. Methods We used the data of patients who were initially diagnosed as gastric GIST and underwent partial gastrectomy. The patients were randomly divided into training dataset and test dataset at a ratio of 3 to 1. After pre-experimental screening, max depth = 2, eta = 0.1, gamma = 0.5, and nrounds = 200 were defined as the best parameters, and in this way we developed the initial extreme gradient-boosting (XGBoost) model. Based on the importance of the features in the initial model, we improved the model by excluding the hematological features. In this way we obtained the final XGBoost model and underwent validation using the test dataset. Results In the initial XGBoost model, we found that the hematological indicators (including inflammation and nutritional indicators) examined before the surgery had little effect on the outcome, so we subsequently excluded the hematological indicators. Similarly, we also screened the features from enhanced CT and ultrasound gastroscopy, and finally determined the 6 most important predictors for GIST diagnosis, including the ratio of long and short diameter under CT, the CT value of the tumor, the enhancement of the tumor in arterial period and venous period, existence of liquid area and calcific area inside the tumor under EUS. Round or round-like tumors with a CT value of around 30 (25–37) and delayed enhancement, as well as liquid but not calcific area inside the tumor best indicate the diagnosis of GIST. Conclusions We developed a model to further differential diagnose GIST from other tumors in initially clinical diagnosed gastric GIST patients by analyzing the results of clinical examinations that most patients should have completed before surgical resection.

Background This study compared intensive and conventional glycemic management strategies in diabetic patients receiving enteral nutrition after gastrectomy. Methods Diabetic patients ( n  = 212) who underwent gastrectomy between September 2006 and March 2014 were randomized to intensive glycemic (IG) management with continuous insulin infusion (target glucose 4.4–6.1 mmol/l (80–110 mg/dl)) or conventional glycemic (CG) management with intermittent bolus insulin (target glucose <11.1 mmol/l (<200 mg/dl)). Outcomes included blood glucose concentrations, insulin administration, and postoperative morbidity and mortality. Results Blood glucose levels were lower (5.4 ± 1.2 vs. 9.5 ± 1.8 mmol/l, P  < 0.001) and mean insulin dose was higher (55 ± 15 vs.32 ± 16 units/day, P  < 0.001) in the IG than in the CG group. Rates of severe hypoglycemia (7.5 vs. 0.9 %, P  = 0.035) and achievement of target blood glucose (86.3 vs. 72.6 %, P  = 0.023) were higher, while severe hyperglycemia rate was lower (1.9 vs. 11.3 %, P  = 0.010), in the IG group. Surgical site infection rate was lower in the IG group (4.7 vs. 13.2 %, P  < 0.030). Rates of other infective complications, bleeding, delayed gastric emptying, obstruction, hepatic dysfunction, renal dysfunction, and circulatory insufficiency were similar in the two groups. Conclusions Intensive glycemic control in diabetic patients receiving enteral nutrition after gastrectomy was associated with a lower surgical site infection rate but a higher hypoglycemia rate.

Background Surgery for gastrointestinal stromal tumor (GIST) at the duodenojejunal junction is a technically challenging and difficult procedure because of the anatomical complexity. When it comes to laparoscopic surgery, it is more challenging than open surgery. This study aimed to introduce our laparoscopic procedure and to evaluate its clinical implication by comparing with open procedures. Method Between 2003 and 2013, 19 patients underwent segmental resection for a GIST at the duodenojejunal junction: laparoscopic segmental resection with side-to-side duodenojejunostomy ( n  = 8) and open surgery ( n  = 11). Clinicopathological findings, operation details, and postoperative outcomes were compared. Results Both groups were comparable in demographics and clinicopathological characteristics. Postoperative hospital stay of the laparoscopic group (6.3 days) was significantly shorter than the open group (15.7 days, P  = 0.008) while no significant differences were observed regarding estimated blood loss, operation time, and morbidity. All patients in both groups underwent curative resection without operative mortality. Two patients experienced recurrence after open surgery whereas none of the patients after laparoscopic duodenojejunostomy had recurrence with a median follow-up period of 36 months. Conclusion Laparoscopic segmental resection with side-to-side duodenojejunostomy for a GIST at the duodenojejunal junction is a safe, feasible, and effective alternative to open approach, providing benefits of minimally invasive surgery.