Alfred Cuschieri

Patient survival after D-1 and D-2 resections for gastric cancer: long-term results of the MRC randomized surgical trial

SummaryControversy still exists on the optimal surgical resection for potentially curable gastric cancer. Much better long-term survival has been reported in retrospective/non-randomized studies with D2 resections that involve a radical extended regional lymphadenectomy than with the standard D1 resections. In this paper we report the long-term survival of patients entered into a randomized study, with follow-up to death or 3 years in 96% of patients and a median follow-up of 6.5 years. In this prospective trial D1 resection (removal of regional perigastric nodes) was compared with D2 resection (extended lymphadenectomy to include level 1 and 2 regional nodes). Central randomization followed a staging laparotomy.Out of 737 patients with histologically proven gastric adenocarcinoma registered, 337 patients were ineligible by staging laparotomy because of advanced disease and 400 were randomized. The 5-year survival rates were 35% for D1 resection and 33% for D2 resection (difference –2%, 95% CI = –12%–8%). There was no difference in the overall 5-year survival between the two arms (HR = 1.10, 95% CI 0.87–1.39, where HR > 1 implies a survival benefit to D1 surgery). Survival based on death from gastric cancer as the event was similar in the D1 and D2 groups (HR = 1.05, 95% CI 0.79–1.39) as was recurrence-free survival (HR = 1.03, 95% CI 0.82–1.29). In a multivariate analysis, clinical stages II and III, old age, male sex and removal of spleen and pancreas were independently associated with poor survival. These findings indicate that the classical Japanese D2 resection offers no survival advantage over D1 surgery. However, the possibility that D2 resection without pancreatico-splenectomy may be better than standard D1 resection cannot be dismissed by the results of this trial.

Postoperative morbidity and mortality after D1 and D2 resections for gastric cancer : preliminary results of the MRC randomised controlled surgical trial

BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer, including extended lymphadenectomy, seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries. There has, however, been no evidence from randomised trials that extended lymphadenectomy (D2 gastric resection) confers a survival advantage. This question was addressed in a trial involving thirty-two surgeons in Europe. METHODS In a prospective randomised controlled trial, D1 resection (level 1 lymphadenectomy) was compared with D2 resection (levels 1 and 2 lymphadenectomy). Central randomisation (200 patients in each arm) followed a staging laparotomy. FINDINGS The D2 group had greater postoperative hospital mortality (13% vs 6.5%; p=0.04 [95% Cl 9-18% for D2, 4-11% for D1] and higher overall postoperative morbidity (46% vs 28%; p<0.001); their postoperative stay was also longer. The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy. In the whole group (400 patients), survival beyond three years was 30% in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50% in the remainder. INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections. These disadvantages are consequent upon additional pancreatectomies and distal splenectomies, and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures.

The european experience with laparoscopic cholecystectomy

A retrospective survey of 7 European centers involving 20 surgeons who undertook 1,236 laparoscopic cholecystectomies was performed. The procedure was completed in 1,191 patients. Conversion to open cholecystectomy was necessary in 45 patients (3.6%) either because of technical difficulty (n = 33), the onset of complications (n = 11), or instrument failure (n = 1). There were no deaths reported, and the total postoperative complication rate was 20 of 1,203 (1.6%), with 9 being serious complications requiring laparotomy. The total incidence of bile duct damage was 4 of 1,203. The median hospital stay was 3 days (range: 1 to 27 days) and the median time to return to full activity after discharge was 11 days (range: 7 to 42 days).

The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery

Background: The pneumoperitoneum is the crucial element in laparoscopic surgery. Different clinical problems are associated with this procedure, which has led to various modifications of the technique. The aim of this guideline is to define the scientifically proven standards of the pneumoperitoneum. Methods: Based on systematic literature searches (Medline, Embase, and Cochrane), an expert panel consensually formulated clinical recommendations, which were graded according to the strength of available literature evidence. Recommendations: Preoperatively, all patients should be assessed for the presence of cardiac, pulmonary, hepatic, renal, or vascular comorbidity. Presupposing appropriate perioperative measures and surgical technique, there is no reason to contraindicate pneumoperitoneum in patients with peritonitis or intraabdominal malignancy. During laparoscopy, monitoring of end tidal CO2 concentration is mandatory. The available data on closed- (Veress needle) and open-access techniques do not allow us to principally favor the use of either technique. Using 2 to 5-mm instead of 5 to 10-mm trocars improves cosmetic result and postoperative pain marginally. It is recommended to use the lowest intraabdominal pressure allowing adequate exposure of the operative field, rather than using a routine pressure. In patients with limited cardiac, pulmonary, or renal function, abdominal wall lifting combined with low-pressure pneumoperitoneum might be an alternative. Abdominal wall lifting devices have no clinically relevant advantages compared to low-pressure (5–7 mmHg) pneumoperitoneum. In patients with cardiopulmonary diseases, intra- and postoperative arterial blood gas monitoring is recommended. The clinical benefits of warmed, humidified insufflation gas are minor and contradictory. Intraoperative sequential intermittent pneumatic compression of the lower extremities is recommended for all prolonged laparoscopic procedures. For the prevention of postoperative pain a wide range of treatment options exists. Although all these options seem to reduce pain, the data currently do not justify a general recommendation.

E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi.

AbstractBackground: The current management of patients with gallstone disease and ductal calculi consists of endoscopic stone extraction (ESE) followed by laparoscopic cholecystectomy (LC). Following the advent of techniques of laparoscopic ductal stone clearance, an alternative single-stage laparoscopic treatment was introduced for these patients. The European Association of Endoscopic Surgery (E.A.E.S.) set up a ductal stone trial to compare the relative efficacy and outcome of these two management options. Methods: A prospective randomized controlled clinical trial compared two management options. Group A (n= 150) received preoperative endoscopic retrograde cholangiography (ERC) with ESE followed by LC during the same hospital admission, and group B (n= 150) received single-stage laparoscopic management. Results: There were no significant differences between the two groups in the clinical demographic details and the pretreatment biochemical findings. In group A, 14 of 150 patients received single-stage treatment; in group B, 17 of 150 were managed by the two-stage approach (protocol violation = 31/300, 10%). In group A patients managed in accordance with randomization, ERC was successful in 129/136 (95%) and preoperative ESE succeeded in 82/98 (84%) with ductal calculi detected by the ERC. Two patients had malignancies and one refused surgery. Thus, 133 patients underwent surgery. Of this group, 116 had LC only and 17 had LC and attempted laparoscopic duct exploration. There were eight conversions to open surgery (6%), 17 complications for both stages (12.8%), and two postoperative deaths (1.5%). In group B patients managed in accordance with randomization, intraoperative cholangiography was successful in 132/133 (99%). Twenty-one (16%) had normal findings, ductal calculi were found in 109, and other pathology was noted in two (periampullary cancer, severe pancreatitis). These two patients and one other (who had gross adhesion in the triangle of Calot) were converted at the start of the procedure. Transcystic ductal stone clearance was successful in 45 of 56 patients (80%), and laparoscopic direct common duct (CBD) exploration was successful in 47 of 55 patients (85%). This group includes 53 patients who underwent primary direct exploration and two failed attempts at transcystic extraction. The conversion rate was 13%. Postoperative complications were encountered in 21 patients (15.8%), and one patient died of a major myocardial infarction (0.75%). The one postoperative death and the 10/11 biliary complications occurred in the laparoscopic supraduodenal CBD exploration subgroup. The conversion rate was higher in group B (17 vs eight; p= 0.08). Laparotomy in the postoperative period was required in three patients in group A and four patients in group B. The group B patients were in hospital for 3 days less than patients who had two-stage management (median, 6.0, IQR = 4.25–12 vs median, 9.0, IQR = 5.5–14; p < 0.05). Conclusions: The results demonstrate equivalent success rates and patient morbidity for the two management options but a significantly shorter hospital stay with the single-stage laparoscopic treatment. The findings indicate that in fit patients (ASA I and II), single-stage laparoscopic treatment is the better option, and preoperative ESE should be confined to poor-risk patients—i.e., those with cholangitis or severe pancreatitis.

Whither minimal access surgery : tribulations and expectations

I n years to come, the advent of laparoscopic cholecystectomy (LC) will be seen as a significant milestone in the history of surgery. Indeed, it is a momentous advance which has already had a momentous impact. Nonetheless, the early post-LC years witnessed an uncontrolled expansion of surgical endoscopic practice, at times not far short of abuse, which amounted to the biggest unaudited freefor-all in the history of surgery. The leaders of our profession lacked the foresight to grasp the implications of Wittmoser and Semm’s pioneering work in laparoscopic and thoracoscopic techniques,‘.2 and the majority of established surgical training departments were totally unprepared to deal with them. By default. then, the unprecedented expansion of minimal access surgery (MAS) was largely a peripheral phenomenon. Now that the dust has settled. it is important to analyze how MAS has altered surgical practice and training and how it will continue to do so in the future. The development of MAS has raised issues that extend beyond the technical aspects of operative patient care. First, it has given prominence to economic concerns that transcend the ongoing debate concerning the relative cost benefit of the new surgical approach versus conventional open surgery. Studies of cost efficacy, utility, and benefit, using objective parameters such as quality-of-life-adjusted years (QALYs), will assume increasing importance as future developments impose extra burdens on limited resources. Regrettably, in the economic area too, the reports on MAS have lacked scientific objectivity, producing wildly different conclusions on the basis of data that are often suspect. One major indirect benefit of MAS has been to emphasize. as never before, the importance of minimizing the trauma of surgical operative treatment-the raison d’&tre of endoscopic surgery.

Randomised study of influence of two-dimensional versus three-dimensional imaging on performance of laparoscopic cholecystectomy

BACKGROUND Several three-dimensional video-endoscopic systems have been introduced to enhance depth perception during minimum-access surgery. However, there is no conclusive evidence of benefit, and these systems are more expensive than conventional two-dimensional systems. We undertook a prospective randomised comparison of two-dimensional and three-dimensional imaging in elective laparoscopic cholecystectomy for symptomatic gallstone disease. METHODS The operations were done by four specialist registrars as part of their higher surgical training. 60 operations were randomised for execution by either two-dimensional or three-dimensional imaging display (30 by each method). The degree of difficulty of the operation was graded by a consultant surgeon on a standard grading system. The primary endpoints were execution time and the errors made during the procedure. The secondary endpoints were subjective assessment of the image quality and adverse effects on the surgeon. FINDINGS There was no difference between the two-dimensional and three-dimensional display groups in median execution time (3160 [IQR 2735-4335 vs 3100 [2379-3710] s; p = 0.2) or error rate (six vs six). Surgeons reported adverse symptoms immediately after the operations with both systems. The scores for visual strain, headache, and facial discomfort were higher with the three-dimensional system. INTERPRETATION With the current technology, three-dimensional systems based on sequential imaging show no advantage over two-dimensional systems in the conduct of laparoscopic cholecystectomy.

Measurements and modelling of the compliance of human and porcine organs

Stress-strain data obtained from animal and human tissue have several applications including medical diagnosis, assisting in surgical instrument design and the production of realistic computer-based simulators for training in minimal access surgery. Such data may also be useful for corroborating mathematical models of tissue response. This paper presents data obtained from ex-vivo and in-vivo tissue indentation tests using a small indentor that is similar to instruments used in minimal access surgery. In addition, uniform stress tests provide basic material property data, via an exponential stress-strain law, to allow a finite element method to be used to predict the response for the non-uniform stresses produced by the small indentor. Data are obtained from harvested pig liver and spleen using a static compliance probe. Data for human liver are obtained from volunteer patients, undergoing minor open surgery, using a sterile hand-held compliance probe. All the results demonstrate highly non-linear stress-strain behaviour. Pig spleen is shown to be much more compliant than pig liver with mean elastic moduli of 0.11 and 4.0 MPa respectively. The right lobe of human liver had a mean elastic modulus of about 0.27 MPa. However, a single case of a diseased liver had a mean modulus of 0.74 MPa--nearly three times the stiffness. It was found that an exponential stress-strain law could accurately fit uniform stress test data and that subsequent finite element modelling for non-uniform stress around a small indentor matched measured force characteristics.

Errors enacted during endoscopic surgery--a human reliability analysis.

The aim of the study was to document the nature and incidence of surgical errors enacted during laparoscopic surgery in order to direct future research and surgical training. A modified Human Reliability Analysis (HRA) approach, based on direct observation, was adopted to categorise and record errors encountered during the practice of laparoscopic cholecystectomy. This study confirmed the applicability and usefulness of an observational methodology in the assessment of human error in endoscopic surgical performance. The study identified aspects of the design and usage of instruments, surgical training and the differences between tasks which needed further directed research in order to identify underlying performance shaping factors (PSFs) and so reduce error rates.

How safe is high-power ultrasonic dissection?

ObjectiveTo evaluate the safety of ultrasonic dissection. Summary Background DataHigh-power ultrasonic dissection is in widespread use for both open and laparoscopic operations and is generally perceived to carry a low risk of collateral damage, but there is no published evidence for this. MethodsUnder controlled experimental conditions, ultrasonic dissections were performed in pigs using Ultracision (Ethicon) or Autosonix (Tyco/USSC) at the three power settings (3, 4, and 5) in random fashion to mobilize the cardia and fundus, bile duct, hepatic artery, portal vein, aorta from the inferior vena cava, renal vessels, colon, and ureters. The dissections (open and laparoscopic) were carried out on pigs at each power setting with each device. Thermal mapping of the tissues during dissection was performed with an infrared thermal camera and associated software. The animals were killed at the end of each experiment and specimens were harvested for quantitative histology. ResultsExtreme and equivalent temperature gradients were generated by ultrasonic dissection with both systems. Heat production was directly proportional to the power setting and the activation time. The core body temperature of the animals after completion of the laparoscopic dissections rose by an average of 2.3°C. The zone around the jaws that exceeded 60°C with continuous ultrasonic dissection for 10 to 15 seconds at level 5 measured 25.3 and 25.7 mm for Ultracision and Autosonix, respectively. At this power setting and an activation time of 15 seconds, the temperature 1.0 cm away from the tips of the instrument exceeded 140°C. Although there was no discernible macroscopic damage, these thermal changes were accompanied by significant histologic injury that extended to the media of large vessels and caused partial- to full-thickness mural damage of the cardia, ureter, and bile duct. Collateral damage was absent or insignificant after dissections at power level 3 with both systems and an activation time not exceeding 5 seconds. ConclusionsHigh-power ultrasonic dissections at level 5 and to a lesser extent level 4 result in considerable heat production that causes proximity collateral damage to adjacent tissues when the continuous activation time exceeds 10 seconds. Ultrasonic dissections near important structures should be conducted at level 3. At power levels of 4 and 5, the ultrasonic energy bursts to the tissue should not exceed 5 seconds at any one time.