Huug Obertop

Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients

For patients with gastric cancer deemed curable the only treatment option is surgery, but there is disagreement about whether accompanying lymph-node dissection should be limited to the perigastric nodes (D1) or should extend to regional lymph nodes outside the perigastric area (D2). We carried out a multicentre randomised comparison of D1 and D2 dissection. 1078 patients were randomised (539 to each group). 26 allocated D1 and 56 allocated D2 were found not to satisfy eligibility criteria (histologically confirmed adenocarcinoma of the stomach without clinical evidence of distant metastasis). Each of the remainder was attended by one of eleven supervising surgeons who decided whether curative resection was possible and, if so, assisted with the allocated procedure. Among the 711 patients (380 D1, 331 D2) judged to have curable lesions, D2 patients had a higher operative mortality rate than D1 patients (10 vs 4%, p = 0.004) and experienced more complications (43 vs 25%, p < 0.001). They also needed longer postoperative hospital stays (median 25 [range 7-277] vs 18 [7-143] days, p < 0.001). Morbidity and mortality differences persisted in almost all subgroup analyses. While we await survival results, D2 dissection should not be used as standard treatment for western patients.

Rates of Complications and Death After Pancreaticoduodenectomy: Risk Factors and the Impact of Hospital Volume

ObjectiveTo perform a two-part study of pancreaticoduodenectomy in the Netherlands, focusing on the effects of risk factors on outcomes in a single high-volume hospital and the effect of hospital volume on outcomes. Summary Background DataHospital volume and surgeon caseload can be related to the rates of complications and death, and the influence of risk factors can be volume-dependent. Provision of regionalized care should take this into account. MethodsIn part A, a single-institution database on 300 consecutive patients undergoing pancreaticoduodenectomy was divided into two periods with similar numbers of patients. Overall complications, deaths, hospital stay, and risk factors were analyzed in the two periods and compared with an historical reference group. In part B, Netherlands medical registry data on age and postoperative death of patients who underwent partial pancreaticoduodenectomy from 1994 to 1998 were analyzed for the influence of hospital volume on death. ResultsBetween the time periods, the institutional death rate decreased from 4.9% to 0.7%, the complication rate from 60% to 41%. Median hospital stay decreased from 24 to 15 days. The death rate was not related to patient age and did not differ between surgeons. Serum creatinine levels, need for blood transfusion, and period of resection were independent risk factors for complications. The death rate after pancreaticoduodenectomy in the Netherlands was 12.6% in 1994 and 10.1% in 1998; it was greater in patients older than age 65. During the 5-year period, 40% of the procedures were performed in hospitals performing fewer than five resections per year, and the death rate was greater than in hospitals performing more than 25 resections per year. ConclusionsThe overall death rate after pancreaticoduodenectomy did not decrease significantly during the period, and it was greater in low-volume hospitals and older patients. The lower death and complication rates in high-volume hospitals, including the single-center outcomes, were similar to those reported in other countries and may be due to better prevention and management of complications. Pancreaticoduodenectomy should be performed in centers with sufficient experience and resources for support.

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.

A Meta-analysis on the Efficacy of Preoperative Biliary Drainage for Tumors Causing Obstructive Jaundice

ObjectiveTo review the effectiveness of preoperative biliary drainage (PBD) in patients with obstructive jaundice resulting from tumors. Summary Background DataThis 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). MethodsComparison 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. ResultsFive 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. ConclusionsThis 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.

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.

Incidence, risk factors, and treatment of pancreatic leakage after pancreaticoduodenectomy: drainage versus resection of the pancreatic remnant.

BACKGROUND Pancreatic leakage is a major cause of morbidity and mortality after pancreaticoduodenectomy, with incidences varying between 6-24% and a mortality rate up to 40%. Treatment is an issue of controversy. In this study we analyzed risk factors for pancreatic leakage and the results of early resection of the pancreatic remnant versus drainage procedures for leakage of the pancreaticojejunostomy. STUDY DESIGN From 1983 to 1995, 269 patients underwent pancreaticoduodenectomy, with pancreaticojejunostomy. Patients with manifestations of pancreatic leakage were compared with nonleakage patients to evaluate risk factors. Patients with leakage were divided into two treatment groups. One group comprised patients undergoing percutaneous or surgical drainage procedures; the other had patients undergoing resection of the pancreatic remnant. RESULTS Twenty-nine patients (11%) had clinical manifestations of pancreatic leakage, and the mortality in these patients was 28% (overall mortality: 3.7%). Leakage occurred after a median of 5 days (range 1-20). Age, preoperative bilirubin level, and albumin counts were not risk factors for pancreatic leakage. Small pancreatic duct size (< 2 mm) (p < 0.01) and ampullary carcinoma as histopathologic diagnosis (p < 0.05) were risk factors. The median number of relaparotomies was two (range 0-4) in the drainage group (n = 21), versus 1.5 (range 1-5) in patients who underwent resection (n = 8). The median hospital stay was 74 days (range 36-219), versus 55 days (range 22-107) for the drainage and resection groups, respectively (p < 0.05). Mortality was lower in patients who underwent resection, 38 versus 0% (p < 0.05). CONCLUSIONS Leakage of the pancreatic anastomosis is a severe complication after pancreaticoduodenectomy and carries a high mortality rate (28%). Completion pancreatectomy could be performed without additional mortality. In patients with severe and persistent leakage of the anastomosis, early completion pancreatectomy is the treatment of choice.

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.

Delayed gastric emptying after standard pancreaticoduodenectomy versus pylorus-preserving pancreaticoduodenectomy: an analysis of 200 consecutive patients

BACKGROUND It has been suggested that pylorus-preserving pancreaticoduodenectomy (PPPD) is associated with a high incidence of delayed gastric emptying and consequently with a prolonged hospital stay compared with standard Whipples resection. The aim of this prospective study was to evaluate whether the incidence of delayed postoperative gastric emptying was different after both procedures. STUDY DESIGN From 1989 to 1996, 200 consecutive patients underwent pancreatic head resection (100 standard pancreaticoduodenectomy [PD]; 100 PPPD). The groups were compared with regard to patient characteristics, operative indices, postoperative morbidity, hospital stay, and mortality. Delayed gastric emptying was defined as nasogastric suction for > or = 10 days or delay of regular diet until > 14 days postoperatively. RESULTS Operative time and blood loss were higher for PD: 6 versus 4.8 hours (p < 0.0001) and 1,580 versus 1,247 mL (p < 0.001), respectively. Postoperative morbidity was 48% after PD and 44% after PPPD (not significant [NS]). Hospital mortality was 6% and 1% after PD and PPPD, respectively (NS). Delayed gastric emptying occurred in 34 patients after PD and in 37 after PPPD (NS). Median days of gastric suction was 3 versus 6 days for PD and PPPD (p < 0.0001). A regular diet was tolerated after a median of 10 and 11 days for PD and PPPD, respectively (NS). Postoperative hospital stay was shorter for patients who underwent PPPD: 20 versus 18 days (p < 0.03). Patients with intraabdominal complications (n = 52) showed a higher incidence of delayed gastric emptying (p < 0.0001). CONCLUSIONS Our results show that PPPD is a safe procedure associated with less operative time and blood loss than PD. After PPPD, patients require longer postoperative nasogastric intubation than after PD, suggesting some form of early postoperative gastric stasis. There is, however, no difference in the incidence of delayed gastric emptying or the first postoperative day on which a regular diet is tolerated between these surgical procedures. Intraabdominal complications are major risk factors for delayed gastric emptying.

Impaired Quality of Life 5 Years After Bile Duct Injury During Laparoscopic Cholecystectomy: A Prospective Analysis

ObjectiveTo assess the impact of bile duct injury (BDI) sustained during laparoscopic cholecystectomy on physical and mental quality of life (QOL). Summary Background DataThe incidence of BDI during laparoscopic cholecystectomy has decreased but remains as high as 1.4%. Data on the long-term outcome of treatment in these patients are scarce, and QOL after BDI is unknown. MethodsOne hundred six consecutive patients (75 women, median age 44 ± 14 years) were referred between 1990 and 1996 for treatment of BDI sustained during laparoscopic cholecystectomy. Outcome was evaluated according to the type of treatment used (endoscopic or surgical) and the type of injury. Objective outcome (interventions, hospital admissions, laboratory data) was evaluated, a questionnaire was filled out, and a QOL survey was performed (using the SF-36). Risk factors for a worse outcome were calculated. ResultsMedian follow-up time was 70 months (range 37–110). The objective outcome of endoscopic treatment (n = 69) was excellent (94%). The result of surgical treatment (n = 31) depended on the timing of reconstruction (overall success 84%; in case of delayed hepaticojejunostomy 94%). Five patients underwent interventional radiology with a good outcome. Despite this excellent objective outcome, QOL appeared to be both physically and mentally reduced compared with controls (P < .05) and was not dependent on the type of treatment used or the severity of the injury. The duration of the treatment was independently prognostic for a worse mental QOL. ConclusionsDespite the excellent functional outcome after repair, the occurrence of a BDI has a great impact on the patient’s physical and mental QOL, even at long-term follow-up.

The effect of preoperative biliary drainage on postoperative complications after pancreaticoduodenectomy

Abstract BACKGROUND: The benefit of preoperative biliary drainage in jaundiced patients undergoing pancreaticoduodenectomy for a suspected malignancy of the periampullary region is still under debate. This study evaluated preoperative biliary drainage in relation to postoperative outcomes. STUDY DESIGN: At the Academic Medical Center, Amsterdam, the Netherlands, a cohort of 311 patients undergoing pancreaticoduodenectomy from June 1992 up to and including December 1999 was studied. Of this cohort 21 patients with external or surgical biliary drainage were excluded and 232 patients who had received preoperative internal biliary drainage were divided into three groups corresponding with severity of jaundice according to preoperative plasma bilirubin levels: 100 μM (n = 23) were designated as groups 1, 2, and 3, respectively. These groups were compared with patients who underwent immediate surgery (n = 58) without preoperative drainage. RESULTS: The median number of stent (re)placements was 2 (range 1 to 6) with a median drainage duration of 41 days (range 2 to 182 days) and a stent dysfunction rate of 33%. Although patients in group 1 were better drained than patients in groups 2 and 3 (median reduction of bilirubin levels 82%, 57%, and 37%, respectively, p CONCLUSIONS: Preoperative biliary drainage did not influence the incidence of postoperative complications, and although it can be performed safely in jaundiced patients it should not be used routinely.