Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

BACKGROUND: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. METHODS: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. RESULTS: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

Histopathological factors predicting response to neoadjuvant therapy in gastric carcinoma

Background. Neoadjuvant therapy (NAT) is a useful therapeutic option. However, some patients respond poorly to it and can even show tumor progression. It is important to define factors that can predict response to NAT. Materials and methods. This is a retrospective cohort study to define histopathological factors predicting response to NAT in gastric tubular carcinoma. This study has enrolled 80 patients receiving chemotherapy for locally advanced gastric carcinoma. Results. 44.5% of the patients were men; mean age was 64.49 years. Only 5.7% of the patients showed a complete response to therapy, 10% had grade 1, 21.4% grade 2, and 62.9% grade 3 regression. On follow-up, 43.8% of the patients showed recurrence of disease (57.1% distant metastasis) and 33.8% eventually died of it. We found a statistically significant association between response and prognosis. We found a statistically significant association between regression and perineural, vascular, and lymph vessel invasion. Logistic regression model showed that only lymph vessel invasion had independent influence. Lymph vessel invasion not only indicated lack of response to therapy, but also higher incidence of lymph node involvement in the gastrectomy specimen. Discussion. Our study indicates that the presence of vascular or perineural invasion in the endoscopic biopsies and high histopathological grade predict poor response to therapy. This seems peculiar, for undifferentiated tumors are supposed to have better response to therapy. Conclusion. Our study indicates that undifferentiated tumors respond worse to therapy. Furthermore, studies are necessary to define lack of response, to help avoid neoadjuvant therapy in unfavorable cases (AU)

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Histopathological factors predicting response to neoadjuvant therapy in gastric carcinoma.

BACKGROUND: Neoadjuvant therapy (NAT) is a useful therapeutic option. However, some patients respond poorly to it and can even show tumor progression. It is important to define factors that can predict response to NAT. MATERIALS AND METHODS: This is a retrospective cohort study to define histopathological factors predicting response to NAT in gastric tubular carcinoma. This study has enrolled 80 patients receiving chemotherapy for locally advanced gastric carcinoma. RESULTS: 44.5% of the patients were men; mean age was 64.49 years. Only 5.7% of the patients showed a complete response to therapy, 10% had grade 1, 21.4% grade 2, and 62.9% grade 3 regression. On follow-up, 43.8% of the patients showed recurrence of disease (57.1% distant metastasis) and 33.8% eventually died of it. We found a statistically significant association between response and prognosis. We found a statistically significant association between regression and perineural, vascular, and lymph vessel invasion. Logistic regression model showed that only lymph vessel invasion had independent influence. Lymph vessel invasion not only indicated lack of response to therapy, but also higher incidence of lymph node involvement in the gastrectomy specimen. DISCUSSION: Our study indicates that the presence of vascular or perineural invasion in the endoscopic biopsies and high histopathological grade predict poor response to therapy. This seems peculiar, for undifferentiated tumors are supposed to have better response to therapy. CONCLUSION: Our study indicates that undifferentiated tumors respond worse to therapy. Furthermore, studies are necessary to define lack of response, to help avoid neoadjuvant therapy in unfavorable cases.

[First non-autologous vascular access for hemodialysis: PTFE fistula]. / Primer acceso vascular no autólogo para hemodiálisis. Prótesis de PTFE humero-antecubital curva de antebrazo.

INTRODUCTION: Since 1999 to 2003 we have tried to perform an antebraquial "loop" PTFE fistula (PTFEa) as first vascular access for hemodialysis in patients without suitable superficial venous system. MATERIAL AND METHODS: We have performed a prospective study to analyze the results (permeability and complications) with this approach. RESULTS: We could perform 44 PTFEa in 46 consecutive patients (in two cases we used the axillary vein as return vessel). Early failure was 0%. One year primary and secondary permeability were 66% and 90% respectively. CONCLUSIONS: PTFEa is a good solution as first vascular access in patients without a suitable superficil venous system.

Liver transplantation for the treatment of fulminant hepatic failure induced by the ingestion of ecstasy.

Methylenedimethoxymethamphetamine (MDMA), more commonly known as ecstasy, is a synthetic amphetamine derivative used by teenagers and young adults in the United States as well as in Western Europe as a "dance drug". Though a number of complications associated with this drug have been reported, there is little information pertaining to hepatoxity as a result of MDMA ingestion. This case report is about an 18-year-old female patient who regularly used ecstasy on weekends over a 2-month period. Within 2 days after accepting a "hit" of the substance at a party, she was admitted to the hospital because of lethargy, vomiting, abdominal pain, stool discoloration, icterus, and darkened urine. On day 7 she developed fulminant hepatic failure with reduced hepatic coagulation factors and grade IV encephalopathy. Orthotopic liver transplantation was carried out 10 days following the ingestion. The patient made a full recovery within 72 h and was released from the hospital 6 weeks later. Histopathological examination of the removed liver revealed a nutritive-toxic liver necrosis. This case demonstrates that the ingestion of ecstasy, even on an infrequent basis, can lead to acute fulminant liver necrosis, and that this life-threatening complication can be treated successfully by liver transplantation.

Orthotopic liver transplantation in primary liver tumors.

Among 283 orthotopic liver transplantations made during the last 6 years at our institution, 22 (7.77%) were done on 19 patients with unresectable hepatic malignant tumors [hepatocellular carcinoma (17), angiosarcoma (1), and cholangiocarcinoma (1)]. None of them showed extrahepatic invasion, and only one had lymph node involvement. Cyclosporin A, corticosteroids, and azathioprine were administered for 3 months after the procedure, and maintenance therapy involved the first two drugs. Acute rejection rate and hospital stay were not significantly different compared with non-tumoral grafted patients. Three patients were retransplanted, one with uncontrolled acute rejection and two with chronic rejection. Intraoperative mortality was zero. Eight patients (42.1%) were alive at a mean follow-up of 31 months (range, 6-74). Four 22.2%) died with tumor recurrence, three of sepsis, two of respiratory insufficiency, one of hepatitis recurrence with cirrhosis, and one of primary lung neoplasia. If adequately selected, primary liver tumor patients may benefit from liver transplantation. Future research with adjuvant therapies will improve the results.

A single technique for polypropylene mesh hernioplasty of inguinal and femoral hernias.

The main factor in the repair of groin hernias is the reinforcement of posterior wall defects of the inguinal canal, including the femoral ring, because the normal insertion of the transversalis fascia and transversus abdominis muscle is on Cooper's ligament and not Poupart's ligament. In approximately one-half of primary femoral hernia repairs in men, a coincidental ipsilateral inguinal hernia existed. Recurrence after inguinal herniorrhaphy is usually femoral. Forty-three patients with direct, large indirect or femoral hernias (primary or recurrent) had a Marlex mesh hernioplasty to treat the inguinal and femoral region simultaneously.

Liver transplantation in malignant primary hepatic neoplasms.

Between April 1986 and August 1990, 151 liver transplantations were performed at our institution, 16 (11%) of them in 14 patients with primary hepatic tumors. There were 12 hepatocellular carcinomas, 1 angiosarcoma, and 1 Klatskin tumor. None of the tumors was resectable, and there was no preoperative evidence of extrahepatic tumoral extension. Exploratory laparotomy was performed prior to transplantation in three patients and selective embolization of the tumor in six patients. There was no difference in the intraoperative requirements for blood or plasma in the patients with hepatic tumors when compared with other transplant recipients (28.6 +/- 23.6 units packed red blood cells [PRBC] versus 20.1 +/- 17.8 units PRBC, and 17.9 +/- 12.2 units plasma versus 17.1 +/- 10.5 units plasma, respectively). Extracorporeal venovenous bypass was used in all but one patient. There was no significant differences in the incidence of acute rejection or in the length of hospitalization in these patients when compared with other transplant recipients. All patients received triple immunosuppressive therapy (corticosteroids, azathioprine, and cyclosporin A). Intraoperative mortality was zero. At a mean of 13.3 months' follow-up (range: 1 to 47 months), 2 of 14 patients had died of sepsis and 1 of terminal cirrhosis (autopsies revealed no evidence of tumor recurrence); 3 patients (21%) had recurrences of the tumor (1 in the central nervous system and liver, and the other 2 in the lung). One of the three patients with a recurrent tumor is still alive after 16 months. The remaining nine patients (64%) are still alive.

Recurrent acute pancreatitis as a complication of cystic fibrosis: report of one case treated surgically.

We present the case of a young woman previously diagnosed with cystic fibrosis (CF) manifested primarily by respiratory symptoms and pancreatic exocrine insufficiency. Only 0.5% of these patients suffer from episodes of recurrent acute pancreatitis, the majority of which respond to conservative treatment. In this case, recurrent episodes of acute pancreatitis made it necessary to perform a surgical pancreatic drainage procedure.