Costs of relaparotomy on-demand versus planned relaparotomy in patients with severe peritonitis: an economic evaluation within a randomized controlled trial.

INTRODUCTION: Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. We now report the full economic evaluation for this trial, including detailed methods, nonmedical costs, further differentiated cost calculations, and robustness of different assumptions in sensitivity analyses. METHODS: An economic evaluation was conducted from a societal perspective alongside a randomized controlled trial in 229 patients with severe secondary peritonitis and an acute physiology and chronic health evaluation (APACHE)-II score >or=11 from two academic and five regional teaching hospitals in the Netherlands. After the index laparotomy, patients were randomly allocated to an on-demand or a planned-relaparotomy strategy. Primary resource-utilization data were used to estimate mean total costs per patient during the index admission and after discharge until 1 year after the index operation. Overall differences in costs between the on-demand relaparotomy strategy and the planned strategy, as well as relative differences across several clinical subgroups, were evaluated. RESULTS: Costs were substantially lower in the on-demand group (mean, 65,768 euro versus 83,450 euro per patient in the planned group; mean absolute difference, 17,682 euro; 95% CI, 5,062 euro to e29,004 euro). Relative differences in mean total costs per patient (approximately 21%) were robust to various alternative assumptions. Planned relaparotomy consistently generated more costs across the whole range of different courses of disease (quick recovery and few resources used on one end of the spectrum; slow recovery and many resources used on the other end). This difference in costs between the two surgical strategies also did not vary significantly across several clinical subgroups. CONCLUSIONS: The reduction in societal costs renders the on-demand strategy a more-efficient relaparotomy strategy in patients with severe peritonitis. These differences were found across the full range of healthcare resources as well as across patients with different courses of disease. TRIAL REGISTRATION: ISRCTN51729393.

[Preventing ineffective laparoscopic cholecystectomies]. / Voorkom onnodige laparoscopische cholecystectomie.

The number of laparoscopic cholecystectomies in the Netherlands has increased significantly in recent years. However, there is a large variation in practice. This is a sign of inefficient use of cholecystectomy. Cholecystectomy is the treatment of choice in patients with uncomplicated symptomatic gallstones, but 30% of the patients has persistent pain after surgery. In a large prospective multicentre randomised trial, a restrictive strategy was compared to usual care in patients with symptomatic gallstones. The results show suboptimal pain reduction in both groups. There were fewer cholecystectomies in the restrictive strategy group and no difference in gallstone related complications between the groups. It is therefore still unclear which patients with gallstones and abdominal symptoms should undergo cholecystectomy. The data could be used in new studies to construct algorithms for patient selection. In the meantime, the use of a decision aid is recommended. Well-informed patients can, in consultation with their doctors, opt for cholecystectomy or a conservative approach. This strategy will lead to fewer unnecessary cholecystectomies.

Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus.

BACKGROUND: Controversy exists about the best surgical treatment for esophageal carcinoma. METHODS: We randomly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy. Principal end points were overall survival and disease-free survival. Early morbidity and mortality, the number of quality-adjusted life-years gained, and cost effectiveness were also determined. RESULTS: A total of 106 patients were assigned to undergo transhiatal esophagectomy, and 114 to undergo transthoracic esophagectomy. Demographic characteristics and characteristics of the tumor were similar in the two groups. Perioperative morbidity was higher after transthoracic esophagectomy, but there was no significant difference in in-hospital mortality (P=0.45). After a median follow-up of 4.7 years, 142 patients had died--74 (70 percent) after transhiatal resection and 68 (60 percent) after transthoracic resection (P=0.12). Although the difference in survival was not statistically significant, there was a trend toward a survival benefit with the extended approach at five years: disease-free survival was 27 percent in the transhiatal-esophagectomy group, as compared with 39 percent in the transthoracic-esophagectomy group (95 percent confidence interval for the difference, -1 to 24 percent [the negative value indicates better survival with transhiatal resection]), whereas overall survival was 29 percent as compared with 39 percent (95 percent confidence interval for the difference, -3 to 23 percent). CONCLUSIONS: Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy. Although median overall, disease-free, and quality-adjusted survival did not differ statistically between the groups, there was a trend toward improved long-term survival at five years with the extended transthoracic approach.

Diagnostic laparoscopy and laparoscopic ultrasound for staging of patients with malignant proximal bile duct obstruction.

Tumor staging in patients with a malignant obstruction of the proximal bile duct is focused on selecting patients who could benefit from a resection. Diagnostic laparoscopy, which has proved its value in several gastrointestinal malignancies, has been used routinely at our hospital since 1993 in patients with a malignant obstruction of the proximal bile duct, although data in the literature with regard to its additional value are conflicting. Therefore the diagnostic accuracy of diagnostic laparoscopy in patients with malignant proximal bile duct obstruction was evaluated. From January 1993 to May 2000, diagnostic laparoscopy was performed in 110 patients (61 males and 49 females), with a mean age of 60 years (range 30 to 80 years), who had a suspected malignant proximal bile duct tumor and in whom "potential resectability" was demonstrated by means of conventional radiologic staging methods (i.e., ultrasound combined with Doppler imaging, CT, endoscopic retrograde cholangiopancreatography, and percutaneous transhepatic cholangiography). Laparoscopy revealed histologically proved incurable disease in 44 (41%) of the 110 patients (31 with metastases and 13 with extensive tumor ingrowth). Laparoscopic ultrasound imaging, however, revealed histologically proved incurable disease in one patient (1%), thereby preventing exploratory laparotomy in 46 because these patients had already been treated by palliative endoscopic stent placement. The remaining 65 patients were staged as having a resectable tumor and underwent surgical exploration. Thirty patients had an unresectable tumor (distant metastases in five; tumor ingrowth in surrounding tissues in 24) or benign disease (one patient). Sensitivity and negative predictive value of diagnostic laparoscopy for detecting unresectable disease were 60% and 52%, respectively. Diagnostic laparoscopy avoided unnecessary laparotomy in 41% of patients with a malignant proximal bile duct obstruction considered resectable according to conventional imaging studies. The additional value of laparoscopic ultrasound was limited. Therefore diagnostic laparoscopy should be performed routinely in the workup of patients with a potentially resectable proximal bile duct tumor.

[Outcomes of 16 years of oesophageal surgery: low postoperative mortality and improved long-term survival]. / Uitkomsten van 16 jaar oesofaguschirurgie: lage postoperatieve mortaliteit en verbeterde langetermijnoverleving.

OBJECTIVE: To assess trends in patient characteristics and treatment outcomes in a large cohort of patients who underwent oesophagectomy for oesophageal carcinoma in a tertiary referral centre over a period of 16 years. DESIGN: Retrospective cohort study. METHODS: We carried out a trend analysis on collected data on demographic and clinico-pathological characteristics, complications and survival of patients who underwent oesophagectomy between January 1993 and December 2008 at the Academic Medical Center in Amsterdam (AMC), the Netherlands. Patients were subsequently divided into three comparably-sized groups according to the year of operation: group 1 (1993-1998; n = 332), group 2 (1999-2004; n = 312), and group 3 (2005-2008; n = 296). RESULTS: A total of 940 patients underwent oesophagectomy during the total study period. Transhiatal oesophagectomy was performed more often during the first two time periods (65 and 64%, respectively), while the transthoracic approach was used more often in the third period (53%). The proportion of patients who underwent a microscopically radical resection increased significantly over the three periods of time. In-hospital mortality in all three periods was low, between 3.2%-3.4%. The three-year survival rate improved significantly over the three periods (p = 0.018), from 42% and 48% to 53% in the most recent period. CONCLUSION: Over the past 16 years in-hospital mortality in patients undergoing oesophagectomy for a potentially curable oesophageal carcinoma at the AMC, has been stably low. The total number of complications increased during these periods. Long-term survival improved during this time to a three-year overall survival of more than 50% in the most recent period.

Postoperative complications after esophagectomy for adenocarcinoma of the esophagus are related to timing of death due to recurrence.

BACKGROUND: Esophagectomy is frequently accompanied by substantial complications with secondary disturbance of the immune system. After esophagectomy for adenocarcinoma of the distal esophagus and/or gastroesophageal junction, the majority of patients develops an early recurrence and dies within 2 years. The aim of this study was to determine the relevance of perioperative complications on the timing of death due to recurrence. METHODS: A consecutive series of 351 patients who underwent esophagectomy for adenocarcinoma of the esophagus and gastroesophageal junction was reviewed. RESULTS: Of the 351 included patients, 191 patients (54%) died due to recurrence of esophageal adenocarcinoma. Of these 191 patients, 77 (40%), 138 (72%), and 186 patients (97%) died before 12, 24, and 60 months, respectively. Multivariate Cox regression analysis demonstrated that T-stage, lymph node ratio >0.20, the presence of extracapsular lymph node involvement, but not complications were significant factors for the prediction of death due to cancer recurrence. However, in the patients who died, multivariate Cox regression analysis demonstrated that not only the presence of extracapsular lymph node involvement but also the occurrence of complications were significantly related with a shorter time interval until death due to recurrence. CONCLUSION: The relation between perioperative complications and cancer recurrence per se is not causal. However, postoperative complications are independently associated with the early timing of death due to cancer recurrence. A possible explanation for this phenomenon is that immunologic host factors enhance microscopic residual disease to develop more rapidly into clinically manifest recurrence.

Referral pattern and timing of repair are risk factors for complications after reconstructive surgery for bile duct injury.

BACKGROUND: The aim of the present study was to assess the role of the referral pattern and the timing of the surgical procedure on outcome after reconstructive surgery for bile duct injury (BDI). SUMMARY BACKGROUND DATA: BDI after laparoscopic cholecystectomy remains a major problem in current surgical practice. Controversy exists about the influence of previous interventions before referral and the timing of repair on outcome. METHODS: Of 500 patients referred to a tertiary center, 151 patients (30.2%) underwent reconstructive surgery for BDI. The influence of referral pattern was analyzed by defining patients as primary and secondary referred patients. The influence of timing of repair was investigated by categorizing 3 groups of patients: A, acute repair; B, delayed repair; and C, late repair. RESULTS: Hospital mortality was zero. Perioperative complications occurred in 29 patients (19.2%): in 26.4% in secondary referred patients and 7.9% in primary referred patients (P = 0.04). Perioperative complications occurred in group A in 33.3%, in group B in 15.6%, and in group C in 22.5% (P = 0.22). Postoperative strictures occurred significantly more often in patients operated in the acute phase (P < 0.01) and in secondary referred patients (P = 0.03). A multivariate analysis identified 3 independent negative predictive factors for outcome: extended injury in the biliary tree (odds ratio = 3.70; confidence interval, 1.32-10.34), secondary referral (odds ratio = 4.35; confidence interval, 1.12-16.76), and repair in the acute phase after injury (odds ratio = 5.44; confidence interval, 1.2-24.43). CONCLUSIONS: Reconstructive surgery for the treatment of BDI is associated with acceptable morbidity and no mortality. Extended injury to the bile duct, referral to a tertiary center after therapeutic interventions, and acute repair are independent negative predictors on outcome after reconstructive surgery for BDI.

Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the mid/distal esophagus: five-year survival of a randomized clinical trial.

OBJECTIVE: To determine whether extended transthoracic esophagectomy for adenocarcinoma of the mid/distal esophagus improves long-term survival. BACKGROUND: A randomized trial was performed to compare surgical techniques. Complete 5-year survival data are now available. METHODS: A total of 220 patients with adenocarcinoma of the distal esophagus (type I) or gastric cardia involving the distal esophagus (type II) were randomly assigned to limited transhiatal esophagectomy or to extended transthoracic esophagectomy with en bloc lymphadenectomy. Patients with peroperatively irresectable/incurable cancer were excluded from this analysis (n = 15). A total of 95 patients underwent transhiatal esophagectomy and 110 patients underwent transthoracic esophagectomy. RESULTS: After transhiatal and transthoracic resection, 5-year survival was 34% and 36%, respectively (P = 0.71, per protocol analysis). In a subgroup analysis, based on the location of the primary tumor according to the resection specimen, no overall survival benefit for either surgical approach was seen in 115 patients with a type II tumor (P = 0.81). In 90 patients with a type I tumor, a survival benefit of 14% was seen with the transthoracic approach (51% vs. 37%, P = 0.33). There was evidence that the treatment effect differed depending on the number of positive lymph nodes in the resection specimen (test for interaction P = 0.06). In patients (n = 55) without positive nodes locoregional disease-free survival after transhiatal esophagectomy was comparable to that after transthoracic esophagectomy (86% and 89%, respectively). The same was true for patients (n = 46) with more than 8 positive nodes (0% in both groups). Patients (n = 104) with 1 to 8 positive lymph nodes in the resection specimen showed a 5-year locoregional disease-free survival advantage if operated via the transthoracic route (23% vs. 64%, P = 0.02). CONCLUSION: There is no significant overall survival benefit for either approach. However, compared with limited transhiatal resection extended transthoracic esophagectomy for type I esophageal adenocarcinoma shows an ongoing trend towards better 5-year survival. Moreover, patients with a limited number of positive lymph nodes in the resection specimen seem to benefit from an extended transthoracic esophagectomy.

Hospital volume and mortality after pancreatic resection: a systematic review and an evaluation of intervention in the Netherlands.

OBJECTIVES: To evaluate the best available evidence on volume-outcome effect of pancreatic surgery by a systematic review of the existing data and to determine the impact of the ongoing plea for centralization in The Netherlands. SUMMARY BACKGROUND DATA: Centralization of pancreatic resection (PR) is still under debate. The reported impact of hospital volume on the mortality rate after PR varies. Since 1994, there has been a continuous plea for centralization of PR in The Netherlands, based on repetitive analysis of the volume-outcome effect. METHODS: A systematic search for studies comparing hospital mortality rates after PR between high- and low-volume hospitals was used. Studies were reviewed independently for design features, inclusion and exclusion criteria, cutoff values for high and low volume, and outcome. Primary outcome measure was hospital or 30-day mortality. Data were obtained from the Dutch nationwide registry on the outcome of PR from 1994 to 2004. Hospitals were divided into 4 volume categories based on the number of PRs performed per year. Interventions and their effect on mortality rates and centralization were analyzed. RESULTS: Twelve observational studies with a total of 19,688 patients were included. The studies were too heterogeneous to allow a meta-analysis; therefore, a qualitative analysis was performed. The relative risk of dying in a high-volume hospital compared with a low-volume hospital was between 0.07 and 0.76, and was inversely proportional to the volume cutoff values arbitrarily defined. In 5 evaluations within a decade, hospital mortality rates were between 13.8% and 16.5% in hospitals with less than 5 PRs per year, whereas hospital mortality rates were between 0% and 3.5% in hospitals with more than 24 PRs per year. Despite the repetitive plea for centralization, no effect was seen. During 2001, 2002, and 2003, 454 of 792 (57.3%) patients underwent surgery in hospitals with a volume of less than 10 PRs per year, compared with 280 of 428 (65.4%) patients between 1994 and 1996. CONCLUSIONS: The data on hospital volume and mortality after PR are too heterogeneous to perform a meta-analysis, but a systematic review shows convincing evidence of an inverse relation between hospital volume and mortality and enforces the plea for centralization. The 10-year lasting plea for centralization among the surgical community did not result in a reduction of the mortality rate after PR or change in the referral pattern in The Netherlands.

Pain management of patients with unresectable peripancreatic carcinoma.

In patients with unresectable peripancreatic carcinoma, pain is generally treated with pain medication or with a celiac plexus blockade. Radiotherapy has also been reported to reduce pain. The efficacy of these treatment modalities is still under discussion. The aim of this study was to analyze the effects of the various types of pain management on patients who underwent palliative bypass surgery for unresectable peripancreatic carcinoma. During the period January 1995 to December 1998 a series of 98 patients underwent palliative bypass surgery, mostly for unresectable disease found during exploration. Patients were divided into three groups: palliative bypass surgery (BP), palliative bypass surgery with an intraoperative celiac plexus blockade (CPB), and palliative bypass surgery with or without celiac plexus blockade followed by high-dose conformal radiotherapy (RT). Radiotherapy was performed only in selected patients with locally advanced disease and without metastases, implying a better prognosis of the last group. The pain medication consumption, pain medication-free survival, hospital-free survival, and overall survival were analyzed. The preoperative consumption of pain medication was significantly higher in the CPB group than in the BP or RT group. The postoperative consumption of pain medication in the CPB, BP, and RT groups increased during follow-up from 15%, 17%, and 13% before surgery to 52%, 57%, and 46%, respectively, at three-fourths of the survival time (NS). This increase in consumption of pain medication was not different in the three groups. In the RT group the median pain medication-free survival was significantly longer than in the BP or CPB group (9.3 vs. 3.1 and 3.3 months; p = 0.02). The median hospital-free survival and median overall survival were significantly longer in the RT group than in the CPB group (10.3 vs. 6.8 months, p = 0.01; and 7.1 vs. 10.8 months, p = 0.01). Celiac plexus blockade as pain management did not result in an increase of the pain medication-free survival or overall survival. Therefore a positive effect of a celiac plexus blockade on pain could not be confirmed in the present study. Radiotherapy resulted in increased pain-medication survival, hospital-free survival, and overall survival compared to celiac plexus blockade. These effects are probably partly related to patient selection.

Aortoesophageal fistula secondary to mycotic thoracic aortic aneurysm: endovascular repair and transhiatal esophagectomy.

PURPOSE: To report a case of aortoesophageal fistula secondary to a mycotic thoracic aortic aneurysm (TAA) successfully repaired by stent-grafting of the descending thoracic aorta. CASE REPORT: A 66-year-old woman with a recent history of hemicolectomy for colon cancer complicated by postoperative infection presented with midthoracic pain, fever, hoarseness, and blood chemistries consistent with an inflammatory process. Imaging showed a widened mediastinum and displacement of the trachea due to a mycotic thoracic aneurysm; endoscopy confirmed a large fistula in the esophageal wall. There was no active bleeding, so an Excluder thoracic endograft was positioned in the aortic arch, partially covering the left subclavian artery origin. Three days later, a transhiatal esophagectomy was performed. Intravenous antibiotic therapy was continued for 6 weeks. At 18 months, a minithoracotomy was performed because of extreme dyspnea. An aneurysm sac hygroma was drained in the thoracic cavity. At 2 years, the patient was well, and there were no signs of infection or dyspnea. CONCLUSIONS: Along with a transhiatal esophagectomy, we suggest that endovascular stent-grafting has a place as a minimally invasive technique in the treatment of aortoesophageal fistula secondary to aneurysm of the thoracic aorta.

Role of surveillance in intestinal metaplasia of the esophagus and gastroesophageal junction.

This article reviews current concepts of cancer surveillance in esophageal columnar metaplasia (Barrett's esophagus) and intestinal metaplasia at the gastroesophageal junction. An overview is given of the available data on the prevalence of intestinal metaplasia in biopsies from the distal esophagus and from the gastroesophageal junction. Furthermore, special attention is given to the endoscopic detection of dysplasia and early malignancy. Finally, the costs of endoscopic surveillance and its effect on mortality rates from esophageal adenocarcinoma are discussed.

A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice.

OBJECTIVE: To review the effectiveness of preoperative biliary drainage (PBD) in patients with obstructive jaundice resulting from tumors. SUMMARY BACKGROUND DATA: This was a systematic review, including a meta-analysis, of randomized controlled trials and comparative cohort studies conducted worldwide and published between 1966 and September 2001, classified on methodologic strength and subdivided into level 1 (randomized controlled trials) and level 2 (comparative cohort studies). METHODS: Comparison was made of PBD versus no PBD in jaundiced patients undergoing resection of a tumor. Outcome measures were in-hospital death rate, overall complications resulting from the treatment modality (drainage- and surgery-related complications), and hospital stay. Effect sizes were calculated and combined in meta-analyses. Relative differences (%) were calculated to compare effects on outcome measures. RESULTS: Five randomized controlled studies comprising 302 patients met the inclusion criteria for level 1 studies, and 18 cohort studies comprising 2,853 patients met the criteria for level 2 studies. Meta-analysis of level 1 studies showed no difference in the overall death rate between patients who had PBD and those who had surgery without PBD. The overall complication rate, however, was significantly adversely affected by PBD compared with surgery without PBD. At level 2, there was no difference in the death rate between the two treatment modalities. The overall complication rate, however, was significantly adversely affected by PBD compared with surgery without PBD. If PBD had been without complications, then complications would be in favor of drainage based on level 1 studies, and no difference based on level 2 studies. Further, PBD was not able to reduce the length of postoperative hospital stay compared with surgery without PBD; instead, it prolonged the stay. CONCLUSIONS: This meta-analysis shows that PBD with current standards for patients with obstructive jaundice resulting from tumors carries no benefit and should not be performed routinely. The potential benefit of PBD in terms of postoperative rates of death and complications does not outweigh the disadvantage of the drainage procedure. Only if PBD-related complications could be reduced by 27% and consequently diminish hospital stay could PBD be beneficial. Further randomized controlled trials with improved PBD techniques are necessary.

Outcome of pancreaticojejunostomy after previous endoscopic stenting in patients with chronic pancreatitis.

OBJECTIVE: To assess whether previous endoscopic stenting of the pancreatic duct influences the outcome of subsequent pancreaticojejunostomy in chronic pancreatitis. DESIGN: Retrospective analysis. SETTING: University hospital, the Netherlands. PATIENTS: 50 patients with chronic pancreatitis, 26 of whom had previously had stents inserted and 24 who had not. INTERVENTIONS: A questionnaire was sent to each patient to evaluate long-term pain relief, readmissions during follow-up and subjective efficacy of the operation, and risk factors for recurrent pain were calculated. MAIN OUTCOME MEASURES: Postoperative morbidity, pain relief and subjective efficacy. RESULTS: Patients with stents were operated on later (after 60 months of symptoms) than those without (17 months). 5 (19%) and 2 (8%) patients developed complications. No patient died. Personal follow-up (median 27 months) was obtained in 41 of 44 available patients (93%). 36 patients (88%) felt that they had benefited from pancreaticojejunostomy. 13 of the 21 patients with stents (62%) and 11 of the 20 patients without stents (55%) reported pain at least monthly, but of these 24 patients 21 patients (88%) had less pain than preoperatively; 11 (22%) had pain daily. 13 patients were readmitted for a relapse of pancreatitis, 3 of whom required partial pancreatectomy. Previous endoscopic stenting of the pancreatic duct was not a risk factor for recurrent pain (p = 0.61). CONCLUSION: Endoscopic stenting of the pancreatic duct may be done for patients with chronic pancreatitis without adverse effects on the outcome of subsequent pancreaticojejunostomy.

Quality of life after colon interposition by necessity for esophageal cancer replacement.

BACKGROUND: After esophagectomy for cancer, the first choice for reconstruction of the gastrointestinal continuity is by gastric tube. When this is not feasible, a reconstruction by colon interposition can be performed. The aim of this study was to assess the quality of life in patients at least 6 months after esophageal cancer resection and colon interposition without signs of recurrent disease. The results were compared with previously published data of patients after esophageal cancer resection and gastric tube reconstruction. PATIENTS AND METHODS: Between January 1993 and January 2002, 36 patients underwent esophageal cancer resection and gastrointestinal reconstruction by colon interposition. A one-time Quality of Life assessment was carried out in 14 patients who were still disease free after a median follow-up of 21 months (mean 35, range 7-97). The patients were visited at home and asked to fill in questionnaires which consisted of the Short Form-36 (SF-36) Health Survey to assess general quality of life, an adapted Rotterdam Symptom Checklist to assess disease-specific quality of life, a visual analogue scale, and an additional questionnaire concerning other specific effects of the operation. RESULTS: All 14 patients returned the completed set of questionnaires. Compared to the previously published results of patients after gastric tube reconstruction patients with a colon interposition scored significantly (P < or = 0.05) lower in five of the eight subscales of the SF-36 questionnaire (i.e. general health, physical role, vitality, social functioning, and mental health). The most frequent symptoms measured by the Rotterdam Symptom Checklist were early satiety after a meal, dysphagia, diarrhea, loss of sexual interest, and fatigue. Six patients could not independently run their housekeeping and four patients still needed artificial enteral nutrition. CONCLUSION: Based on the SF-36 questionnaire, patients after colon interposition by necessity have a poor general quality of life. Even long after the operation they have a broad spectrum of persisting symptoms. Prior to surgery, patients should be informed about the disabling long-term functional outcome of a colon interposition.

Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial.

BACKGROUND: Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified. METHODS: We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was recurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat. FINDINGS: 12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy. INTERPRETATION: A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high.

Laparoscopic staging and subsequent palliation in patients with peripancreatic carcinoma.

OBJECTIVE: To test the hypothesis that laparoscopic staging improves outcome in patients with peripancreatic carcinoma compared to standard radiology staging. SUMMARY BACKGROUND DATA: Diagnostic laparoscopy of peripancreatic malignancies has been reported to improve assessment of tumor stage and to prevent unnecessary exploratory laparotomies in 10% to 76% of patients. METHODS: Laparoscopy and laparoscopic ultrasound were performed in 297 consecutive patients with peripancreatic carcinoma scheduled for surgery after radiologic staging. Patients with pathology-proven unresectable tumors were randomly allocated to either surgical or endoscopic palliation. All others underwent laparotomy. RESULTS: Laparoscopic staging detected biopsy-proven unresectable disease in 39 patients (13%). At laparotomy, unresectable disease was found in another 72 patients, leading to a detection rate for laparoscopic staging of 35%. In total, 145 of the 197 patients classified as having "possibly resectable" disease after laparoscopic staging underwent resection (74%). Average survival in the group of 14 patients with biopsy-proven unresectable tumors randomly allocated to endoscopic palliation was 116 days, with a mean hospital-free survival of 94 days. The corresponding figures were 192 days and 164 days in the 13 patients allocated to surgical palliation. CONCLUSIONS: Because of the limited detection rate for unresectable metastatic disease and the likely absence of a large gain after switching from surgical to endoscopic palliation, laparoscopic staging should not be performed routinely in patients with peripancreatic carcinoma.