European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery.

BACKGROUND: In recent years, the use of Indocyanine Green (ICG) fluorescence-guided surgery during open and laparoscopic procedures has exponentially expanded across various clinical settings. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference on this topic with the aim of creating evidence-based statements and recommendations for the surgical community. METHODS: An expert panel of surgeons has been selected and invited to participate to this project. Systematic reviews of the PubMed, Embase and Cochrane libraries were performed to identify evidence on potential benefits of ICG fluorescence-guided surgery on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by the panel; they were then submitted to all EAES members through a two-rounds online survey and results presented at the EAES annual congress, Barcelona, November 2021. RESULTS: A total of 18,273 abstracts were screened with 117 articles included. 22 statements and 16 recommendations were generated and approved. In some areas, such as the use of ICG fluorescence-guided surgery during laparoscopic cholecystectomy, the perfusion assessment in colorectal surgery and the search for the sentinel lymph nodes in gynaecological malignancies, the large number of evidences in literature has allowed us to strongly recommend the use of ICG for a better anatomical definition and a reduction in post-operative complications. CONCLUSIONS: Overall, from the systematic literature review performed by the experts panel and the survey extended to all EAES members, ICG fluorescence-guided surgery could be considered a safe and effective technology. Future robust clinical research is required to specifically validate multiple organ-specific applications and the potential benefits of this technique on clinical outcomes.

Safety and efficacy of laparoscopic wedge gastrectomy for large gastrointestinal stromal tumors.

BACKGROUND: Although the feasibility of minimally invasive resection of small gastric GISTs is well established, less is known about safety and efficacy of laparoscopic surgery for large tumors. METHODS: A retrospective analysis was performed, using a prospectively maintained comprehensive database. Patients were divided into two groups according to tumor size: Case group with tumors > 5 cm and control group with tumors <5 cm. Hospital charts were reviewed, and various outcome measures recorded, including operative time, estimated operative blood loss, post-operative leak, stasis, infection and recurrence. RESULTS: No tumors were ruptured during surgical manipulation and no major morbidity or mortality occurred in either group. Operative time (75,8 ± 33,1 min in large cases vs 75,8 ± 33,1 min in small cases) was similar in both groups (p = 0,61). The incidence of post-operative complications did not differ between the two groups. In details there were 21 out of 25 (84%) uncomplicated cases among small GISTs versus 17 out of 24 (70,8%) uncomplicated cases among large GISTs (p = 0,32). CONCLUSION: This matched-pair case control study demonstrates that laparoscopic wedge resection for large gastric GISTs is safe and effective, as demonstrated for small tumors.

Shorter myotomy on the gastric site (≤2.5 cm) provides adequate relief of dysphagia in achalasia patients.

The right length of the myotomy on the gastric side for esophageal achalasia is still a debated issue. We aimed to investigate the final outcome after classic myotomy (CM) as compared with a longer myotomy on the gastric side (LM) in two cohorts of achalasia patients. Forty-four achalasia patients who underwent laparoscopic Heller-Dor were considered; patients with a sigmoid-shaped esophagus were excluded. Symptoms were scored using a detailed questionnaire for dysphagia, regurgitation, and chest pain. Barium swallow, endoscopy, and esophageal manometry were performed before and 6 months after the surgical treatment; 24-hour pH-monitoring was also performed 6 months after the procedure. CM was defined as a gastric myotomy length in the range of 1.5-2.0 cm, while LM was 2.5-3 cm in length. The surgical treatment (CM or LM) was adopted in two consecutive cohorts. Treatment failure was defined as a postoperative symptom score >10th percentile of the preoperative score (i.e. >8). Of the 44 patients representing the study population, 20 had CM and 24 had LM. The patients' demographic and clinical parameters (age, sex, symptom score, duration of symptoms, esophageal diameter, and manometric pattern) were similar in the two groups. The median follow up was 24 months (interquartile range 12-39). One patient in each group was classified as a treatment failure. After the treatment, there was a significant decrease in both groups' symptom score, and resting and residual pressure (P < 0.01), with no statistically significant differences between the two groups in terms of postoperative symptom score, resting and residual pressure, or total and abdominal lower esophageal sphincter length and esophageal diameter. Extending the length of the myotomy on the gastric side does not seem to change the final outcome of the laparoscopic Heller-Dor procedure.

Laparoscopic treatment of post-hysterectomy colovaginal fistula in diverticular disease. Case report.

Colonic diverticular disease is a benign condition typical of the Western world, but it is not rare for even the 1st episode of diverticulitis to carry potentially fatal complications. The evolution of a peridiverticular process generally poses problems for medical treatment and exposes patients to repeated episodes of diverticulitis, making surgical treatment necessary in approximately 30% of symptomatic patients. One of the most worrying complications of diverticulosis is internal fistula. The most common types of fistula are colovesical and colovaginal, against which the uterus can act as an important protective factor. The symptoms and the clinical and instrumental management of patients with diverticular fistulas are much the same as for patients with episodes of acute diverticulitis. Staging of the disease (according to Hinchey) should be done promptly so that the necessary action can be taken prior to surgery, implementing total parenteral nutrition (TPN), nasogastric aspiration and broad-spectrum antibiotic treatment. The best surgical approach to adopt in patients with diverticulitis complicated by fistula is still not entirely clear, though the 3-step strategy is currently tending to be abandoned due to its high morbidity and mortality rates. There is a widespread conviction, however, that the 2-step strategy (Hartmann, or resection with protective stomy) and the 1-step alternative should be reserved, respectively, for patients in Hinchey stages 3, 4 and 1, 2 with a situation of attenuated local inflammation. The 1-step approach seems to be safe and effective. This report describes a case of colovaginal fistula in a patient with colonic diverticulosis who had recently undergone hysterectomy, but who, unlike such cases in the past, was treated in a single step using a laparoscopic technique.

Early rupture of subclavian vein catheter: a case report and literature review.

Prolonged venous access devices (PVADs) have become indispensable in antiblastic protocols for the treatment of cancer patients, in anti-infection protocols for acquired immunodeficiency syndrome (AIDS) patients and in the management of chronic malabsorption syndromes. Using these catheters carries the risk of several complications, and some are potentially lethal, for example, cardiac embolization of catheter fragments. Rupture is a complication almost exclusive to catheters positioned percutaneously: after using this technique, device malfunction can occur due to catheter kinking after its excessively medial introduction in the subclavian vein. The early recognition of any pinch-off sign (POS) is fundamental in preventing catheter rupture that frequently follows this complication. Other factors can be involved in early rupture, for example, excessive force on a syringe used to clear a catheter that shows early signs of malfunction, or a strength defect in the materials used in the catheter construction. This report describes an early rupture case of an initially correctly positioned catheter and reviews 20 such cases in the recent literature.

Mycophenolate mofetil (MMF) versus azathioprine (AZA) in pancreas transplantation: a single-center experience.

AIM: Advances in immunosuppression and careful monitoring for rejection are largely responsible for improved results in pancreas transplantation. We conducted a retrospective study to establish the effectiveness of immunosuppressive therapy with mycophenolate mofetil (MMF) instead of azatioprine (AZA) in pancreas transplantation and to assess adverse effects in the two different immunosuppressive regimes. SUBJECTS AND METHODS: Since 1991, 27 pancreas transplantations were performed in 25 patients at our Institute. For induction therapy, immunosuppressant protocol consisted of quadruple immunosuppressive therapy with cyclosporine, steroids, antilymphocyte globulin and AZA in 13 patients or MMF in 12 patients respectively. RESULTS: Acute rejection occurred in 76% of patients in the AZA group compared with 53% in the MMF group. Steroid-resistant rejection was observed in 7% in the MMF group compared to 38% of patients on AZA (p < 0.01). Two kidney grafts were lost due to acute rejection in the AZA group, one pancreas was lost due to acute rejection and one to chronic rejection in the MMF group. There were no significant differences in CMV infection. Severe fungal infections were noted in 2 patients treated with MMF. Malignancy occurred in 1 patient (pancreas graft lymphoma) in MMF. CONCLUSIONS: In conclusion, patients treated with MMF required less frequent and less intensive treatment for acute rejection. However, its short- and long-term side effects should be further investigated.

Effects of gemfibrozil on insulin sensitivity and on haemostatic variables in hypertriglyceridemic patients.

In order to assess the efficacy of gemfibrozil on lipid and haemostatic parameters in patients with plurimetabolic syndrome, a multicenter double-blind placebo controlled, parallel study was carried out in 56 patients with primary hypertriglyceridemia and glucose intolerance. These patients had elevated PAI activity and antigen and t-PA antigen levels at rest and after venous occlusion. Gemfibrozil reduced plasma triglyceride levels (P<0.001), whereas it increased free fatty acids (P<0.05) and high density lipoprotein cholesterol levels (P<0.05). In those patients reaching normalization of plasma triglyceride levels (triglyceride reduction > or =50%) (n=15), insulin levels (P<0.05) as well as the insulin resistance index were reduced by gemfibrozil treatment, suggesting an improvement of the insulin resistance index in this patient subgroup. Gemfibrozil treatment did not affect plasma fibrinolysis or fibrinogen levels, despite marked reduction of plasma triglycerides and improvement of the insulin sensitivity associated with triglyceride normalization.

Fibrinogenolysis and thrombin generation after reduced dose bolus or conventional rt-PA for pulmonary embolism. The Coagulation Project Investigators of the Bolus Alteplase Pulmonary Embolism Group.

The aim of this study was to compare the effects on fibrinogenolysis and thrombin generation of two recombinant tissue-type plasminogen activator (rt-PA) regimens in patients with pulmonary embolism entering a randomised, controlled study with a 1:2 allocation ratio to rt-PA, 100 mg over 2 h (Group A) or rt-PA, 0.6 mg/kg, maximum dose 50 mg, over 15 min (Group B). In both groups the heparin infusion was stopped 2-4 h before starting thrombolytic treatment and resumed accordingly to the activated partial thromboplastin time (aPTT) or thrombin clotting time (TcT). Seventeen patients in Group A and 30 patients in Group B were evaluated before starting thrombolytic treatment and 2, 6 and 24 h after its end for the following parameters: aPTT, TcT, fibrinogen, fibrinogen degradation products (FDP), plasmin-alpha 2 antiplasmin (PAP) and thrombin-antithrombin III (TAT) complexes. The two groups had similar coagulation parameters at baseline. Two h after starting rt-PA, the aPTT was more prolonged in Group A than in Group B patients (P = 0.01). Patients in Group B showed less reduction in plasma fibrinogen levels at all study times after rt-PA treatment (P = 0.008). The increase in plasma FDP (P = 0.037) and PAP (P = 0.001) levels was lower at 2 and 6 h samples in Group B compared with Group A. TcT was prolonged (P = 0.003) and TAT increased (P = 0.001) during treatment without differences between the two groups. AUC0-24 of fibrinogen, FDP and PAP levels confirmed the statistically significant differences (P = 0.04) between the two groups over the entire 24 h period of the study. Three patients in Group A (17.6%) and three (10.0%) in Group B suffered major or other important bleeding. Our results indicate that the administration of weight-adjusted reduced-dose rt-PA bolus produces less impairment of blood coagulation than the FDA approved regimen.

Post discharge clinically overt venous thromboembolism in orthopaedic surgery patients with negative venography--an overview analysis.

A high incidence of post-discharge venous thromboembolism in orthopaedic surgery patients has been recently reported drawing further attention to the unresolved issue of the optimal duration of the pharmacological prophylaxis. We performed an overview analysis in order to evaluate the incidence of late occurring clinically overt venous thromboembolism in major orthopaedic surgery patients discharged from the hospital with a negative venography and without further pharmacological prophylaxis. We selected the studies published from January 1974 to December 1995 on the prophylaxis of venous thromboembolism after major orthopaedic surgery fulfilling the following criteria: 1) adoption of pharmacological prophylaxis, 2) performing of a bilateral venography before discharge, 3) interruption of pharmacological prophylaxis at discharge in patients with negative venography, and 4) post-discharge follow-up of the patients for at least four weeks. Out of 31 identified studies, 13 fulfilled the overview criteria. The total number of evaluated patients was 4120. An adequate venography was obtained in 3469 patients (84.1%). In the 2361 patients with negative venography (68.1%), 30 episodes of symptomatic venous thromboembolism after hospital discharge were reported with a resulting cumulative incidence of 1.27% (95% C.I. 0.82-1.72) and a weighted mean incidence of 1.52% (95% C.I. 1.05-1.95). Six cases of pulmonary embolism were reported. Our overview showed a low incidence of clinically overt venous thromboembolism at follow-up in major orthopaedic surgery patients discharged with negative venography. Extending pharmacological prophylaxis in these patients does not appear to be justified. Venous thrombi leading to hospital re-admission are likely to be present but asymptomatic at the time of discharge. Future research should be directed toward improving the accuracy of non invasive diagnostic methods in order to replace venography in the screening of asymptomatic post-operative deep vein thrombosis.

Increased plasma levels of tissue factor pathway inhibitor (TFPI) after n-3 polyunsaturated fatty acids supplementation in patients with chronic atherosclerotic disease.

This double-blind, randomised, controlled study examined the effect of a daily dosage of 3 g n-3 polyunsaturated fatty acids (n-3 PUFA) on plasma lipids and some haemostatic factors in 40 patients with chronic atherosclerotic diseases. Serum lipids, factor VII, tissue factor pathway inhibitor (TFPI) and prothrombin activation fragment 1 + 2 (F1 + 2) were measured at baseline and after 2, 8, and 16-week supplementation of either n-3 PUFA or corn oil. Administration of n-3 PUFA promptly lowered serum triglycerides and increased LDL-cholesterol (-32% and +33%, respectively, after 2 weeks of treatment) while a significant increase (+31%) in HDL-cholesterol was documented at the end of the observation period. Treatment with n-3 PUFA induced a progressive significant increase of TFPI plasma levels (+21% after 16 weeks; p = 0.029). TFPI activity was significantly correlated with LDL-cholesterol, and multiple stepwise regression analysis showed that LDL-cholesterol was the most important predictor of TFPI activity. Plasma levels of the inhibitor showed also a very high parallelism in their trend over time (ANOVA model for homogeneity of slopes) with both HDL-cholesterol (p = 0.82) and LDL-cholesterol (p = 0.67). Patients treated with n-PUFA also showed a significant reduction of F1 + 2 plasma levels (p = 0.016) while no significant changes were detected in plasma factor VII clotting activity. Lipid and haemostatic parameters were not modified at any study time in patients receiving corn oil as placebo. The results of this study confirm the effects of n-3 PUFA administration on plasma lipids and show that in patients with chronic atherosclerotic disease a 16-week supplementation with these compounds induces a small but statistically significant increase of TFPI plasma levels with a parallel down-regulation of the extrinsic pathway of blood coagulation which may be relevant to the antithrombotic activity of fish diet and fish oil derivatives.

Distribution and occlusiveness of thrombi in patients with surveillance detected deep vein thrombosis after hip surgery.

Venous thromboembolism is a leading cause of in-hospital postoperative morbidity and mortality. Postoperative deep vein thrombosis (DVT) is usually asymptomatic. A number of studies have consistently shown that the non invasive diagnostic methods are inaccurate in the screening of asymptomatic DVT. Failure of non invasive diagnostic methods to detect thrombi in asymptomatic patients has been suggested to be due to the features of thrombi in these patients. The aim of this study was to assess the distribution and the occlusiveness of thrombi in a series of 321 asymptomatic hip surgery patients with adequate bilateral venography of the lower limbs. Venography was performed 10 +/- 1 days after hip surgery. DVT was found in 180 limbs (28.0%). The distribution of thrombi was as follows: 26 (14.4%) isolated proximal thrombi, 55 (30.6%) proximal and distal thrombi, 99 (55.0%) isolated calf thrombi. We found that 14 of the 81 proximal trombi (17.3%) involved the superficial femoral vein either as exclusive location or in association with calf veins. An involvement of common femoral, superficial femoral and popliteal vein was observed in 37 (45.7%), 39 (48.1%) and 44 (54.3%) cases of the 91 proximal DVT. These thrombi were non occlusive in 25 (67.6%), 22 (56.4%) and 26 (59.1%) limbs, respectively. An involvement of at least one peroneal, anterior tibial and posterior tibial veins was observed in 118, 13 and 89 cases of the 220 distal thrombi. These thrombi were non occlusive in 61 (51.7%), 10 (76.9%) and 30 (33.7%) of the cases. We conclude that the majority of thrombi found in asymptomatic hip surgery patients are non occlusive. In view of this, non invasive diagnostic methods based upon venous flow measurement will be unlikely to improve the diagnosis of asymptomatic DVT. The high incidence of isolated superficial femoral vein thrombosis necessitates that real-time B-mode ultrasonography should be performed examining the entire proximal venous system.

Effects of desmopressin on hemostasis in patients with liver cirrhosis.

The aim of this double-blind, placebo-controlled crossover study was to investigate the effect of 1-deamino-8-D-arginine vasopressin (dDAVP) on hemostasis in patients with chronic liver disease. Nine consecutive patients with biopsy-proven liver cirrhosis and related coagulation abnormalities received in a random order dDAVP, 0.5 microgram/kg, or saline intravenously. Blood samples were taken before dDAVP infusion and 30, 60 and 180 min after its end. dDAVP infusion induced a statistically significant shortening of the bleeding time from 9 min (range 6.5-15.5) to 6 min (range 4.5-9.5) at 1 h after the infusion. The activated partial thromboplastin time was significantly shortened at 30 and 60 min after dDAVP infusion. Plasma levels of factor VIII, XI and XII coagulant activities were significantly increased at all sampling times after dDAVP infusion. The maximum increase over basal values in plasma levels of factor VIII, XI and XII was 63, 22 and 40%, respectively. dDAVP did not induce any significant changes of prothrombin time, thrombin clotting time, fibrinogen, plasma levels of factor II, V, VII, IX, X, factor XII antigen, protein C (activity and antigen), antithrombin III, plasminogen and alpha 2-antiplasmin. Placebo infusion did not produce any significant changes in the evaluated parameters. We conclude that dDAVP can positively influence the hemostatic system in patients with liver cirrhosis. The clinical relevance of this hemostatic improvement deserves further evaluation.

A simple chromogenic substrate assay of tissue factor pathway inhibitor activity in plasma and serum.

A simple chromogenic substrate assay for the quantitation of tissue factor pathway inhibitor (TFPI) activity in plasma or serum samples was developed. After immobilization on microtiter plates for 20 hours at 4 degrees C, a commercial thromboplastin was incubated for 1 hour at room temperature with 1 U/mL of a prothrombin complex concentrate (Protromplex). After washing, solid-phase Factor Xa activity was measured by a chromogenic substrate (S-2222). Factor Xa generation was progressively inhibited when increasing amounts (1-12 microL) of heated serum or plasma, and recombinant TFPI (1-5 ng/mL), were coincubated with Protromplex. Inhibition by serum or plasma was abolished by anti-TFPI polyclonal antibodies. Plasma levels of TFPI in 25 healthy volunteers were found to be 0.98 +/- 0.19 U/mL (range 0.71-1.52), with an intra- and inter-assay coefficient of variation of 10.7 and 11.1%, respectively. The use of a recombinant human thromboplastin improved the sensitivity and reproducibility of the assay. Plasma levels of TFPI were found to be normal in 10 women at the end of their pregnancies, in 10 patients receiving oral anticoagulant therapy, and in 10 diabetic patients. Significantly higher levels were detected in 10 patients with chronic liver disease and in 10 patients with unexplained juvenile thrombosis. In patients with cardiovascular disease, a 7-day treatment with subcutaneous standard heparin increased TFPI activity. The availability of a simple and rapid assay to measure TFPI that does not require purified coagulation proteins may facilitate studies of the pathophysiologic relevance of this inhibitor.