P. De Simone

Minimally invasive surgery for gastric cancer

AbstractBackground: The use of laparoscopic surgery in the treatment of gastric cancer has not yet met with widespread acceptance; thus, it should be regarded as still in the developmental phase. Nevertheless, the laparoscopic approach appears to have some valuable advantages for the management of gastric cancer patients, and it can be expected to have a dramatic impact on public health expenditures. Herein we present the results of our experience with laparoscopic and laparoscopy-assisted gastrectomies for cancer, and we discuss the role of these procedures in current surgical practice.n Methods: Between June 1993 and November 1997, we performed a total of 13 laparoscopic procedures on 13 patients affected with gastric carcinoma. There were eight male and five female patients with a mean age of 65.4 years (range, 42–78). All patients were staged preoperatively with US and CT scan and required to sign a formal consent.n Results: Altogether we performed nine D1 laparoscopic total gastrectomies, seven of which were done with a laparoscopy-assisted approach; three D2 laparoscopy-assisted total gastrectomies, associated in one case with a distal pancreasectomy; and one laparoscopy-assisted distal gastrectomy performed on a morbid obese patient. The preliminary laparoscopic staging allowed for a better definition of tumor extension and identification of undetected hepatic metastases in two patients. The mean duration of the intervention was 240 min. Blood losses were as high as 300 cc on average. We recorded one major intraoperative complication, consisting of an inadvertent injury to the proper hepatic artery, which was successfully repaired by the same laparoscopic route. The postoperative course was uneventful in all patients but one, who died of acute hepatic failure on day 6. At a mean follow-up of 27.5 months, 11 patients are still alive. Two of them have hepatic metastases and nine are disease-free.n Conclusions: Although they remain challenging procedures, laparoscopic gastrectomies appear to be oncologically adequate. We believe that a pure laparoscopic approach should be reserved for low-stage lesions (N0, up to T2), while a combined approach is preferable for locally advanced cancer (N1 or higher, T3 or higher). Much work still needs to be done to establish the optimal strategy in both open and laparoscopic surgery, but laparoscopy can be a valuable tool in the decision-making process for patients affected with gastric malignancies.

Laparoscopic gastric reduction surgery. Preliminary results of a randomized, prospective trial of laparoscopic vs open vertical banded gastroplasty.

AbstractBackground: The purpose of the current study was to present the preliminary results of a randomized prospective trial comparing laparoscopic and open vertical banded gastroplasty (Mason’s procedure).n Methods: From April 1995 to April 1996, 68 patients (9 men and 59 women, mean age, 36 years; ranges, 17–60 years) affected from morbid obesity (mean body weight, 123 kg; range, 89–188 kg; mean body mass index (BMI), 43 kg/m2; range, 37–66 kg/m2) were enrolled in a prospective trial and randomly assigned to a laparoscopic (group A) or open (group B) Mason’s gastroplasty. There was no statistically significant difference between the two groups in terms of patient epidemiologic data. The significance level among the data was assessed by means of Fisher’s exact test.n Results: The success of laparoscopic gastroplasty was 88.2% (30/34). The intervention was significantly longer in the laparoscopic group (150 min vs. 60 min; p= 0.001). No mortality was recorded in the overall population. Intraoperative complications included only one case of gastric bleeding in group A (2.9% vs. 0%; p value not significant [NS]). Early major complications ranged as high as 6.6% and 7.8%, respectively, in groups A and B (p= NS), and included one case of peritonitis and one case of pneumonia in group A, and two cases of peritonitis and one pulmonary embolism in group B. Early minor postoperative complications consisted of wound infections only, observed in one group A patient (3.3%) and four group B patients (10.8%, p= 0.04). At longer follow-up, incisional hernias occurred in 15.8% (6/38) of patients surgically treated with a conventional approach compared with none among those successfully surgically treated with laparoscopic accesss (p= 0.04). No statistically significant difference was observed between the two groups regarding the efficacy of the procedure, in terms of decrease in percentage of excess body weight, mean body weight, or mean BMI.n Conclusions: The preliminary results of current study show that the laparoscopic Mason procedure is a time-consuming and technically demanding operation, as effective as its traditional counterpart, but carrying a statistically significant decrease in the incidence of wound infections and incisional hernias.

Direct trocar insertion vs Veress needle in nonobese patients undergoing laparoscopic procedures: a randomized prospective single-center study.

BackgroundNonobese patients undergoing laparoscopic procedures present a dilemma as to the correct mode of entry into the abdominal cavity because the Veress needle (VN) technique seems to be associated with a high risk of vascular and visceral injuries. Direct trocar insertion (DTI) has been reported as an alternative to the VN for creation of the pneumoperitoneum.MethodsAn open comparative randomized prospective study was conducted on the feasibility and safety of DTI vs the VN technique in nonobese patients of any age category referred for urgent or scheduled laparoscopic procedures. Exclusion criteria were obesity (defined as a body mass index [BMI] > 27 kg/m2), major abdominal distension, and two or more previous abdominal operations. The study endpoints were the feasibility and safety of the DTI and VN techniques. Results were evaluated on an intention-to-treat basis. Statistical analysis was carried out with the t-test for independent samples, the chi-square tests, and the Fisher’s exact tests, as appropriate. The level of significance was 0.01.ResultsSince January 2002, a total of 598 nonobese patients have been entered into the current trial; 46% (mean BMI 21.6 ± 4.4 kg/m2) were randomly allocated to DTI, whereas 54% (BMI 21.1 ± 5.3 kg/m2) were allocated to the VN techniques. Demographic features and type of procedures were similar for the two groups. DTI was feasible in 100% of patients vs 98.7% in the VN group (p = NS). Minor complications were nil in the DTI group and 5.9% in the VN group (p < 0.01). The latter group consisted of 11 cases (3.4%) of subcutaneous emphysema and eight cases (2.5%) of extraperitoneal insufflation. Major complications were nil in the DTI group and 1.3% among VN patients (p = NS). These latter cases consisted of two (0.3%) hepatic lesions managed laparoscopically; one (0.3%) misdiagnosed ileal perforation requiring reintervention, and one (0.3%) mesenteric laceration treated conservatively.ConclusionIn thin and very thin patients of any age category with no more than one previous abdominal operation, DTI is a safe alternative to the VN technique and is associated with fewer minor complications. In terms of major complications, there is no difference between the two techniques. Either technique of access is acceptable Thin and very thin patients undergoing laparoscopy, on condition that the basic principles of laparoscopic surgery are complied with.

Alternative laparoscopic management of perforated peptic ulcers

Surgery—namely, suture closure-is still the treatment of choice for perforated peptic ulcers, despite the proven efficacy of Taylors conservative approach. Such conservative management, however, has been proven less effective in high-risk patients and those with perforations more than 12 h old. Here we suggest alternative laparoscopic treatments for perforated peptic ulcers.We have treated laparoscopically six patients (one F, five M; mean age 57.6 years; range 31–81 years); the mean duration of the operation was 52 min; the median hospital stay was 7 days (6–15 days); H2-blockers, antibiotics, and fluids were administered in the p.o. course; the follow-ups range from 6 to 18 months.On the basis of our experience, the treatment of choice for perforated peptic ulcers is Taylors conservative procedure and laparoscopic drainage of the abdominal cavity when there is mild peritoneal reaction (usually less than 6 h from the onset of perforation). In case of remarkable peritonitis (usually more than 12 h), it is mandatory to add an accurate lavage. When the site of perforation is concealed by the peritoneal inflammation it should not be searched; when visible, it might be obliterated with the round ligament or an omental tissue strand, particularly if larger than 1 cm in diameter.

The impact of everolimus on renal function in maintenance liver transplantation

We retrospectively investigated the impact on renal function (RF) of conversion from calcineurin inhibitors (CNI) to everolimus (EVL) monotherapy in orthotopic liver transplant (OLT) recipients. Between January 2006 and July 2007, 70 deceased donor OLT recipients including 51 men and 19 women of overall mean age of 55.9 +/- 11 years were enrolled into a program of conversion to EVL monotherapy at a mean interval of 45 +/- 35.9 months from transplantation (range, 7-192 months). The indication for conversion was deteriorating RF in 64 (91.4%). Efficacy failure was defined as the persistence of CNI, EVL discontinuation, death, graft loss, loss to follow-up, or need for dialysis at 12 months. Twelve months after switching, 53 patients (75.7%) were on EVL monotherapy. Their mean change in creatinine clearance (CrCl) from baseline (day 1 before EVL introduction) to endpoint (12 months) was 5.8 +/- 13.1 mL/min. On univariate and multivariate analyses, the clinical variable correlated with the greatest probability of improvement was the baseline CrCl (P < .0001). Conversion from CNI to EVL monotherapy was successful in 75.7% of cases with improvement in RF correlated with baseline CrCl. These data supported preemptive minimization of CNI in the posttransplant course, seeking to delay the decline in RF.

Successful Use of Extended Criteria Donor Grafts With Low to Moderate Steatosis in Patients With Model for End-Stage Liver Disease Scores Below 27

Liver transplantation may be performed using extended criteria donor grafts (ECDg). The characteristics of ECDg include age >60 years, long intensive care unit (ICU) stay, history of malignancy or steatosis. Grafts are often discarded due to steatosis, which can be macrovesicular (MaS) or microvesicular (MiS). MaS is the variety most frequently involved with unfavorable outcomes due to primary nonfunction (PNF) or primary dysfunction (PDF). As of January 2000, all livers referred to our institution were considered potentially transplantable. Steatosis was defined as the presence of fat droplets in more than 5% of hepatocytes. We observed 35 steatotic grafts. Grafts were stratified according to MaS and MiS as follows: low steatosis (5%-15%), mild steatosis (16%-30%), moderate steatosis (31%-60%), or severe steatosis (>60%). Fifteen grafts with moderate (n = 2) or severe (n = 13) MaS were discarded. Twenty grafts were harvested: 18 of them were transplanted at our institution, the remaining 2, discarded by our donor team, were transplanted by other Italian centers. Low MaS was detected in 10 grafts (50%), mild MaS in 4 (20%), and moderate MaS in 2 (10%). Low MiS was detected in 8 grafts (40%), mild MiS in 5 (25%), and moderate MiS in 1 (5%). Steatotic grafts were transplanted only into recipients with model for end-stage liver disease (MELD) scores <27. The 6-month graft survival was 80%; the PNF rate was 10%; and the PDF rate was 15%. The careful use of ECDg with low to moderate steatosis is possible if particular care is taken to avoid additional risk factors related to the recipient.

The role of preoperative investigations in predicting difficult laparoscopic cholecystectomies

AbstractBackground: When we began laparoscopic cholecystectomy (LC) we set up a strict preoperative workup in order to assess whether currently available investigations could help predict difficult laparoscopic procedures.nMethods: Reported here are the results of a prospective trial carried out in our first 200 consecutive patients, who underwent routine intravenous cholangiography (IVC), abdominal ultrasound scan (US), blood tests—namely, markers of biliary stasis (MBS)—and preoperative endoscopic retrograde cholangiopancreatography (ERCP) in case of clinically suspected common bile duct stones (CBDS).nResults: On the basis of our experience we think that the US findings relate to the difficulty of the laparoscopic procedure more closely than the other preoperative investigations, and the association of US and liver chemistry provides an accurate evaluation of biliary stones.nConclusions: In agreement with data emerging from the literature, the preoperative investigations do not seem to be useful in predicting biliary and vascular complications, whose prevention lies in the adoption of correct surgical technique and a low threshold for conversion.

The Quality Assurance Program of Organ Donation in Tuscany

Constant monitoring is paramount in order to detect the criticalities and improve the results of the deceased donation process. Concomitant with the institution of a regional transplantation service authority--Organizzazione Toscana Trapianti--in 2003, Tuscany adopted a program of quality assurance of the deceased donation process by compulsory reporting of all encephalic deaths from local intensive care units to the regional transplant office in Florence. The indicators we adopted were the efficiency of deceased donor (DD) identification, expressed as the ratio of encephalic deaths (ED) to total deaths with encephalic lesions (EL) (ie, ED/EL); the efficiency of DD reporting, expressed as the ratio of reported potential DD (RPDD) to total ED (ie, RPDD/ED); the efficacy of the DD process, as the ratio between actual DD (ADD) to total ED (ie, ADD/ED); the conversion rate; the percent of opposition to donation; and the incidence of DD maintenance failures. Data were collected prospectively, stratified by regional hospital consortia (Aziende Sanitarie Locali) and compared with international benchmarks. In the period 2003-2006 the mean efficiency of DD identification was 48.3%+/-4.4% (range 42.6%-53.2%); the mean efficiency of DD reporting was 95.2%+/-2.5% (range 92.5%-98.5%); the mean efficacy of the deceased donation process was 51.8%+/-2.4% (range 48.6%-54.4%); the mean conversion rate was 59.6%+/-2.2% (range 57.6%-62.7%); the mean opposition rate was 31.9%+/-1.1% (range 30.6%-33.2%); and the incidence of DD maintenance failure was 5%+/-2.9% (range 2.2%-8.7%). The breakdown analysis revealed wide interhospital variability in terms of efficiency of DD identification (from a low of 25% to a high of 80%); efficacy of the donation process (from a low of 22% to a high of 79%); and conversion rate (from a low of 29% to a high of 79%). Our results highlight that the donation process gets started in about 50% of eligible cases. Further strategies are favored to address this critical area.

The Epidemiology of Brain Death in Tuscany: Is There Need for Novel Indicators?

Quality monitoring of the donation process requires appropriate indicators. We performed a retrospective review of all patients with encephalic lesions (ELs) reported to the Tuscany Quality Program of Donation during 2003 to 2007, seeking to assess whether there were differences in the brain-death-to-patients-with-encephalic-lesions (BD/EL) ratio, which is a current indicator of the efficiency of the donation process. The theoretical framework was that the type of disease may influence the probability of BD, and the subsequent donation process. During the study period 2555 patients were reported to display ELs. The overall BD/EL ratio was 48.1%, that is, 1229 patients were reported to be BD donors to the regional coordinating center at a later time point during patient hospitalization. With regard to the etiology, 1374 (53.8%) patients suffered cerebrovascular (CV disease); 514 (20.1%) traumatic (T); 397 (15.5%) postanoxic (PA); 55 (2.1%) neurological neoplasms (NN); and 215 (8.4%) other diseases (O). The BD/EL ratio by disease type was 57.2% for CV (786/1374); 58% for T (298/514); 19.4% for PA (77/397); 36.4% for NN (20/55); and 22.3% for O subjects (48/215). Despite its limitations, the current analysis advocates stratification of deceased donors by type of disease to allow better understanding and monitoring of the donation process.

The You Are Not Alone Care Program for Liver Transplantation

Current clinical practice is based on the principles of efficacy, appropriateness, efficiency, quality, and safety. Compliance with these tenets requires experienced medical and nursing staff, and active participation of patients and their families in the planned therapeutic program. To match patients expectations on quality and safety of care and spur active participation in the transplant care process, we set up an integrated, multiphase, multidisciplinary care program devoted to liver transplantation (LT) candidates, engrafted patients, and their families: the Non Sei Solo care program (You Are Not Alone). The basic principle of the care program was that, to provide efficient and effective education to their patients, health care professionals need to learn how to teach and what to teach, acquire successful communication skills, and monitor the process of education. The methodology encompassed 5 distinct phases: phase 1, exploration of patients needs, by means of a questionnaire devoted to waitlisted and engrafted patients and their care givers; and phase 2, creation of 16 patient-oriented educational brochures directed to patients and their families. Once created, the educational brochures were presented, discussed, and amended during a consensus meeting involving all transplantation nurses and physicians (phase 3). To acquire the necessary skills and ease communication with patients, the transplantation nurses, physicians, surgeons, and anesthesiologists attended a 6-month counseling course under the tutorial of an expert counselor (phase 4). Finally, in June 2007 the program started officially with monthly meetings with patients and their families, guided hospital tours on patient request, and activation of a toll-free phone number to provide support to patients and answer their questions.