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1.
Efficacy and Safety of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Operation for Gastrointestinal Malignancy in Japanese Patients: A Multicenter, Open-Label, Prospective, Randomized Controlled Trial.
Obitsu, T, Tanaka, N, Oyama, A, Ueno, T, Saito, M, Yamaguchi, T, Takagi, A, Rikiyama, T, Unno, M, Naitoh, T, et al
Journal of the American College of Surgeons. 2020;(5):501-509.e2
Abstract
BACKGROUND The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; therefore, standard prevention protocols have not been established, especially for minimally invasive procedures. We aimed to investigate the additional effect of low molecular weight heparin (LMWH) on prevention of VTE after laparoscopic surgery for gastrointestinal malignancy. STUDY DESIGN From February 2013 to January 2017, 400 patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients), in which enoxaparin sodium (20 mg [= 2000 IU] twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced CT or ultrasonography when symptomatic or D-dimer was ≥10 μg/mL. RESULTS VTE was observed in 1.2% and 4.0% of patients in the LMWH and Control groups, respectively (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR 1.02, 95% CI 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR 0.21, 95% CI 0.03-0.99), male sex (OR 0.12, 95% CI 0.01-0.60), and early cancer (OR 0.17, 95% CI 0.02-0.82) reduced the risk of VTE. CONCLUSIONS Postoperative LMWH administration is safe. The additional effect of LMWH administration on the physical therapy was not statistically proven in this study. However, it could be useful for the patients with risk factors such as female sex, long operation time, and higher cancer stage.
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2.
TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial.
Chen, YI, Wyse, J, Lu, Y, Martel, M, Barkun, AN
Gastrointestinal endoscopy. 2020;(2):321-328.e1
Abstract
BACKGROUND AND AIMS TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding. METHODS Adult patients presenting with acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality. RESULTS A preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, age 67.2 ± 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P = .057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P = .170). CONCLUSIONS This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding. (Clinical trial registration number: NCT02135627.).
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3.
Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial.
Obling, SR, Wilson, BV, Pfeiffer, P, Kjeldsen, J
Clinical nutrition (Edinburgh, Scotland). 2019;(1):182-190
Abstract
OBJECTIVE Preventing loss of muscle mass and function is an enduring challenge in malnourished patients with incurable cancer. The benefit of supplemental home parenteral nutrition has not been firmly established. Our aim was to evaluate the effects of supplemental home parenteral nutrition, the primary endpoint being fat free mass (FFM) and secondary: muscle function, quality of life and overall survival. DESIGN AND METHODS In a single centre open-label randomised controlled trial, patients with incurable gastrointestinal cancer, nutritionally at risk, were randomly assigned to either; a) best practice nutritional care and dietetic counselling (non-sHPN) or b) dietetic counselling and supplemental home parenteral nutrition (sHPN group). Treatment duration was 24 weeks with visits every six weeks for five scheduled visits. Main outcome was gain in bioelectrical impedance analyses (BIA) estimated FFM. Secondary outcomes were muscle strength, quality of life and survival. RESULTS Eligible for inclusion were 234 patients, 47 of these accepted enrolment; 25 were randomized to non-sHPN and 22 to sHPN according to performance status, age and diagnoses. Median age was 66.9 (41.5-88.2), BMI 21.3 (14.8-35.7) and (91%) were receiving palliative chemotherapy. Median FFM and fat free mass index increased in the sHPN group. At 12 weeks a significant difference (p < 0.01) was found between the groups; in the sHPN group 69% of the patients (versus 40%) increased their FFM. Handgrip strength increased in both groups but without significance between the two. Quality of life at 12 weeks was significantly better (p < 0.05) in the sHPN group. No difference was noticed in survival, median 169 (CI 88-295) days versus 168 (CI 80-268) days. Study completion was accomplished by 36%; 60% died before end of study. CONCLUSIONS Providing supplemental home parenteral nutrition may prevent loss of FFM, and it is even possible to increase FFM in patients with incurable gastrointestinal cancer. Supplementation with parenteral nutrition might have a temporarily positive impact on quality of life. TRIAL REGISTRATION (NCT02066363) www.clinicaltrials.gov.
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4.
Effect of oral nutritional supplementation on the post-discharge nutritional status and quality of life of gastrointestinal cancer patients after surgery: a multi-center study.
Zhu, MW, Yang, X, Xiu, DR, Yang, Y, Li, GX, Hu, WG, Wang, ZG, Cui, HY, Wei, JM
Asia Pacific journal of clinical nutrition. 2019;(3):450-456
Abstract
BACKGROUND AND OBJECTIVES To evaluate the effect of oral nutritional supplementation (ONS) on the postdischarge nutritional status and quality of life (QoL) of gastrointestinal cancer patients after surgery. METHODS AND STUDY DESIGN A multi-center study was conducted on gastrointestinal cancer patients who received surgical treatment from 2013-2015. All patients were screened using the Nutrition Risk Screening 2002 (NRS 2002) to assess nutritional risk. Patients with nutritional risk were randomized into two groups: patients in the study group (n=55) were given dietary guidance and ONS, control group (n=59) received only dietary guidance. Anthropometric measurements, nutrition-related laboratory tests, and gastrointestinal function scores were also collected and analyzed using Student's t test and analysis of variance (ANOVA). In addition, the EQ-5D was used to evaluate patients' QoL. RESULTS Compared with baseline measurements, the body weight of patients in the study group increased by 1.35±0.53 kg and 1.35±0.73 kg at 60 and 90 days, which were significantly higher than those in the control group (-1.01±0.54 kg, and -1.60±0.81 kg at 60 and 90 days). The results from ANOVA showed that only weight and BMI differed significantly between the study and control groups and also between different measurement times (p<0.01). No differences were found for the other indicators or QoL between the study groups. CONCLUSIONS ONS may improve the weight and BMI of surgically treated gastrointestinal cancer patients postdischarge. However, these effects had little impact on patients' QoL.
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5.
Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery.
Zhang, B, Xu, F, Hu, P, Zhang, M, Tong, K, Ma, G, Xu, Y, Zhu, L, Chen, JDZ
The American journal of gastroenterology. 2018;(7):1026-1035
Abstract
BACKGROUND Functional gastrointestinal disturbance occurs after abdominal surgeries and could last for an extended period of time in some cases. This study was designed (1) to evaluate the effects of needleless transcutaneous electrical acustimulation (TEA) on postoperative recovery, and (2) to investigate the mechanisms involving autonomic function in postoperative patients after removal of gastrointestinal cancers. METHODS Forty-two patients (33 male, age: 69.5 ± 1.5 years) scheduled for abdominal surgical removal of gastrointestinal cancers were randomized to TEA (n = 21) and sham-TEA (n = 21). TEA was performed via acupoints ST36 and PC6 1 h twice daily from the postoperative day (POD) 1 to day 3. Sham-TEA was performed at non-acupoints. RESULTS (1) TEA improved major postoperative symptoms by about 30%, including a reduction in time to defecation by 31.7% (P < 0.01 vs. sham-TEA), time to first flatus by 35.9% (P < 0.001), time to ambulation by 42.8% (P < 0.01), time to resuming diet by 26.5% (P < 0.01) and hospital stay by 30% (P < 0.05) as well as pain score by 50% (P < 0.01). (2) TEA significantly increased vagal activity (P < 0.001) and decreased sympathetic activity on POD 4 (P < 0.001) compared with POD 1 as well as the serum level of NE (P < 0.05). (3) The vagal activity, high frequency assessed from the spectral analysis of heart rate variability, was negatively correlated with time to resuming diet, whereas the sympathetic measurement, serum norepinephrine was positively correlated with time to resuming diet and time to flatus. (4) TEA but not sham-TEA decreased TNF-α by 17.4% from POD 1 to POD 4. (5) TEA was an independent predictor of a shorter hospital stay. CONCLUSIONS Needleless TEA improves major postoperative symptoms by enhancing vagal and suppressing sympathetic activities.
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A process and mechanism of action evaluation of the effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: a study protocol.
Furness, K, Huggins, CE, Hanna, L, Silvers, MA, Cashin, P, Low, L, Croagh, D, Haines, TP
BMC cancer. 2018;(1):1181
Abstract
BACKGROUND Cancers of the upper gastrointestinal tract commonly result in malnutrition, which increases morbidity and mortality. Current nutrition best practice lacks a mechanism to provide early and intensive nutrition support to these patients. A 3-arm parallel randomised controlled trial is testing the provision of a tailored, nutritional counselling intervention delivered using a synchronous, telephone-based approach or an asynchronous, mobile application-based approach to address this problem. This protocol outlines the design and methods that will be used to undertake an evaluation of the implementation process, which is imperative for successful replication and dissemination. METHODS A concurrent triangulation mixed methods comparative analysis will be undertaken. The nutrition intervention will be provided using best practice behaviour change techniques and communicated either via telephone or via mHealth. The implementation outcomes that will be measured are: fidelity to the nutrition intervention protocol and to the delivery approach; engagement; acceptability and contextual factors. Qualitative data from recorded telephone consultations and written messages will be analysed through a coding matrix against the behaviour change techniques outlined in the standard operating procedure, and also thematically to determine barriers and enablers. Negative binomial regression will be used to test for predictive relationships between intervention components with health-related quality of life and nutrition outcomes. Post-intervention interviews with participants and health professionals will be thematically analysed to determine the acceptability of delivery approaches. NVivo 11 Pro software will be used to code for thematic analysis. STATA version 15 will be used to perform quantitative analysis. DISCUSSION The findings of this process evaluation will provide evidence of the core active ingredients that enable the implementation of best practice nutrition intervention for people with upper gastrointestinal cancer. Elucidation of the causal pathways of successful implementation and the important relationship to contextual delivery are anticipated. With this information, a strategy for sustained implementation across broader settings will be developed which impact the quality of life and nutritional status of individuals with upper gastrointestinal cancer. TRIAL REGISTRATION 27th January 2017 Australian and New Zealand Clinical Trial Registry ( ACTRN12617000152325 ).
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7.
Efficacy of Early Enteral Immunonutrition on Immune Function and Clinical Outcome for Postoperative Patients With Gastrointestinal Cancer.
Luo, Z, Wang, J, Zhang, Z, Li, H, Huang, L, Qiao, Y, Wang, D, Huang, J, Guo, L, Liu, J, et al
JPEN. Journal of parenteral and enteral nutrition. 2018;(4):758-765
Abstract
BACKGROUND Nutrition support is crucial for patients with gastrointestinal (GI) cancer after the operation. However, the controversy over the application of parenteral nutrition (PN) and early enteral immunonutrition (EEIN) has no determinate conclusion. MATERIALS AND METHODS We compared the effects of PN and EEIN on the postoperative nutrition condition, immune status, inflammation level, long-term survival, and quality of life of the patients with GI cancer. Seventy-eight patients were randomly divided into the PN group (n = 44) or EEIN group (n = 34). After an 8-day nutrition treatment, clinical and immunological parameters were evaluated. RESULTS The EEIN group had a significantly shorter hospital stay and higher body mass index level on postoperative day 30 than those in the PN group (P < .05). However, total hospital cost and incidences of short-term postoperative complications had no significant difference (P > .05). The percentages of CD4+ , natural killer, and natural killer T lymphocyte cells and the ratio of CD4+ /CD8+ in peripheral blood were significantly increased. Compared with the PN group, the EEIN group had a higher expression of activated cell surface markers such as CD27 and CD28. In addition, the secretion of interleukin (IL)-2 and interferon-γ was significantly higher, and the secretion of tumor necrosis factor-α and IL-10 was lower. Complication-free survival in the EEIN group were longer than those in the PN group (P = .04). CONCLUSION EEIN is superior to PN in improving nutrition status, enhancing immune function, and elevating quality of life.
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A randomised trial of post-discharge enteral feeding following surgical resection of an upper gastrointestinal malignancy.
Froghi, F, Sanders, G, Berrisford, R, Wheatley, T, Peyser, P, Rahamim, J, Lewis, S
Clinical nutrition (Edinburgh, Scotland). 2017;(6):1516-1519
Abstract
BACKGROUND Patients undergoing upper gastrointestinal surgery often eat poorly post-operatively, despite dietetic input. A pilot study was conducted to examine the benefit of a 6 week nutritional supplementation via a feeding jejunostomy on fatigue, quality of life and independent living. METHODS A feeding jejunostomy was placed routinely at oesophagectomy or total gastrectomy for cancer. At discharge, patients were randomised to nutritional supplementation (600 kcal/day) via their feeding jejunostomies or no jejunal supplement. Patients were assessed at discharge and 3, 6, 12 and 24 weeks following discharge for fatigue (MFI-20), quality of life (QLQ-OES18), health economic analysis (EQ5D) as well as completing a two-day dietary diary. RESULTS 44 patients (M:F, 29:15) were randomised, 23 received jejunal supplements. There were no differences between the groups. Percentage of calculated energy requirement received was greater in the supplemented group at weeks 3 and 6 (p < 0.0001). Oral energy intake was not different between the groups at any time period. After hospital discharge, there were no differences in MFI-20, EQ5D and QLQ-OES18 scores at any time point. From hospital discharge fatigue improved and plateaued at 6 weeks (p < 0.05 for both groups), independence at 12 weeks (p < 0.05 for both groups). No improvement was seen in quality of life until 24 weeks in the active group alone (p < 0.02) and not at all in the control group. CONCLUSIONS Addition of jejunal feeding is effective in providing patients with an adequate energy intake. Increased energy intake however, produced no obvious improvement in measures of fatigue, quality of life or health economics.
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9.
[Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial].
Zhou, Q, Zuo, MH, Li, QW, Tian, YT, Xie, YB, Wang, YB, Yang, GY, Ye, YJ, Guo, P, Liu, JP, et al
Zhonghua zhong liu za zhi [Chinese journal of oncology]. 2017;(12):919-925
Abstract
Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group (P=0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group (P=0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups (P=0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer. Trial registration: International Standard Randomized Controlled Trial Number Register, ISRCTN18291857.
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10.
Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies.
Wu, HT, Yang, XJ, Huang, CQ, Sun, JH, Ji, ZH, Peng, KW, Zhang, Q, Li, Y
World journal of surgical oncology. 2016;(1):246
Abstract
BACKGROUND This work was to evaluate the perioperative safety and efficacy of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) with lobaplatin and docetaxel in patients with peritoneal carcinomatosis (PC) from gastrointestinal and gynecological cancers. METHODS Patients were treated by CRS + HIPEC with lobaplatin 50 mg/m(2) and docetaxel 60 mg/m(2) in 6000 mL of normal saline at 43 ± 0.5 °C for 60 min. Vital signs were recorded for 6 days after CRS + HIPEC procedures. Perioperative serious adverse events (SAE), hematological, hepatic, renal, and electrolytes parameters, the changes in serum tumor markers (TM) before and after operation, patient recovery, and overall survival (OS) were analyzed. RESULTS One hundred consecutive PC patients underwent 105 CRS + HIPEC procedures and postoperative chemotherapy. The median CRS + HIPEC duration was 463 (range, 245-820) min, and the highest temperature and heart rate during six postoperative days were 38.6 °C (median 37.5 °C) and 124 bpm (median 100 bpm), respectively. The 30-day perioperative SAE occurred in 16 (15.2 %) and mortality occurred in 2 (1.9 %) patients. Most routine blood laboratory tests at 1 week after surgery turned normal. Among 82 cases with increased preoperative TM CEA, CA125, and CA199, 71 cases had TM levels reduced or turned normal. Median time to nasogastric tube removal was 5 (range, 3-23) days, to liquid food intake 6 (range, 4-24) days, and to abdominal suture removal 15 (range, 10-30) days. At the median follow-up of 19.7 (range, 7.5-89.2) months, the median OS was 24.2 (95 % CI, 15.0-33.4) months, and the 1-, 3-, and 5-year OS rates were 77.5, 32.5, and 19.8 %, respectively. Univariate analysis identified five independent prognostic factors on OS: the origin of PC, peritoneal cancer index, completeness of CRS, cycles of adjuvant chemotherapy, and SAE. CONCLUSIONS CRS + HIPEC with lobaplatin and docetaxel to treat PC is a feasible procedure with acceptable safety and can prolong the survival in selected patients with PC. TRIAL REGISTRATION ClinicalTrials.gov, NCT00454519.