Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases: Patient-Reported Outcomes of a Randomized Phase II Trial.

BACKGROUND: As part of a randomized phase II trial in patients with isolated resectable colorectal peritoneal metastases (CPMs), the present study compared patient-reported outcomes (PROs) of patients treated with perioperative systemic therapy versus cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) alone. Also, PROs of patients receiving perioperative systemic therapy were explored. PATIENTS AND METHODS: Eligible patients were randomized to perioperative systemic therapy (experimental) or CRS-HIPEC alone (control). PROs were assessed using EORTC QLQ-C30, QLQ-CR29, and EQ-5D-5L questionnaires at baseline, after neoadjuvant treatment (experimental), and at 3 and 6 months postoperatively. Linear mixed modeling was used to compare five predefined PROs (visual analog scale, global health status, physical functioning, fatigue, C30 summary score) between arms and to longitudinally analyze PROs in the experimental arm. RESULTS: Of 79 analyzed patients, 37 (47%) received perioperative systemic therapy. All predefined PROs were comparable between arms at all timepoints and returned to baseline at 3 or 6 months postoperatively. The experimental arm had worsening of fatigue [mean difference (MD) + 14, p = 0.001], loss of appetite (MD + 15, p = 0.003), hair loss (MD + 18, p < 0.001), and loss of taste (MD + 27, p < 0.001) after neoadjuvant treatment. Except for loss of appetite, these PROs returned to baseline at 3 or 6 months postoperatively. CONCLUSIONS: In patients with resectable CPM randomized to perioperative systemic therapy or CRS-HIPEC alone, PROs were comparable between arms and returned to baseline postoperatively. Together with the trial's previously reported feasibility and safety data, these findings show acceptable tolerability of perioperative systemic therapy in this setting.

Prehabilitation to improve postoperative outcomes in patients with peritoneal carcinomatosis undergoing hyperthermic intraperitoneal chemotherapy (HIPEC): A scoping review.

BACKGROUND: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) leads to increased survival rates in patients with peritoneal carcinomatosis, but is associated with considerable morbidity and mortality rates. Prehabilitation, a process to optimize a patient's preoperative functional capacity, has a positive impact on recovery after colorectal surgery. The impact of prehabilitation in patients undergoing HIPEC is scarcely investigated. This scoping review and narrative synthesis aims to summarize and evaluate what is currently reported about the effect of prehabilitation on postoperative outcomes after HIPEC. METHODS: A literature search of studies reporting on the effect of prehabilitation on outcomes after HIPEC was performed (August 2020). Study characteristics, patient demographics, composition of prehabilitation programs, and reported outcomes used to quantify the effect of prehabilitation were recorded. RESULTS: The literature search did not yield any studies on the effect of prehabilitation programs on outcomes after HIPEC. As an alternative, studies identifying modifiable risk factors for poor postoperative outcomes after HIPEC that can be targeted by prehabilitation were reviewed to evaluate starting points for prehabilitation. Fourteen studies identify the following preoperative factors: poor nutritional status, poor performance status, low health related quality of life and an history of smoking. CONCLUSION: No research has been published on the effect of prehabilitation prior to HIPEC. This review demonstrates that preoperative modifiable risk factors for outcomes in patients undergoing HIPEC are multifactorial. A multimodal prehabilitation program prior to HIPEC, including nutritional support, psychical exercise, psychological support and smoking cessation, might therefore be a promising approach to improve postoperative outcomes.

Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial.

BACKGROUND: Selecting patients with peritoneal metastases from colorectal cancer (CRCPM) who might benefit from cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is challenging. Computed tomography generally underestimates the peritoneal tumor load. Diagnostic laparoscopy is often used to determine whether patients are amenable for surgery. Magnetic resonance imaging (MRI) has shown to be accurate in predicting completeness of CRS. The aim of this study is to determine whether MRI can effectively reduce the need for surgical staging. METHODS: The study is designed as a multicenter randomized controlled trial (RCT) of colorectal cancer patients who are deemed eligible for CRS-HIPEC after conventional CT staging. Patients are randomly assigned to either MRI based staging (arm A) or to standard surgical staging with or without laparoscopy (arm B). In arm A, MRI assessment will determine whether patients are eligible for CRS-HIPEC. In borderline cases, an additional diagnostic laparoscopy is advised. The primary outcome is the number of unnecessary surgical procedures in both arms defined as: all surgeries in patients with definitely inoperable disease (PCI > 24) or explorative surgeries in patients with limited disease (PCI < 15). Secondary outcomes include correlations between surgical findings and MRI findings, cost-effectiveness, and quality of life (QOL) analysis. CONCLUSION: This randomized trial determines whether MRI can effectively replace surgical staging in patients with CRCPM considered for CRS-HIPEC. TRIAL REGISTRATION: Registered in the clinical trials registry of U.S. National Library of Medicine under NCT04231175 .

Extended Resections for Advanced Gallbladder Cancer: Results from a Nationwide Cohort Study.

BACKGROUND: Extended resections (i.e., major hepatectomy and/or pancreatoduodenectomy) are rarely performed for gallbladder cancer (GBC) because outcomes remain inconclusive. Data regarding extended resections from Western centers are sparse. This Dutch, multicenter cohort study analyzed the outcomes of patients who underwent extended resections for locally advanced GBC. METHODS: Patients with GBC who underwent extended resection with curative intent between January 2000 and September 2018 were identified from the Netherlands Cancer Registry. Extended resection was defined as a major hepatectomy (resection of ≥ 3 liver segments), a pancreatoduodenectomy, or both. Treatment and survival data were obtained. Postoperative morbidity, mortality, survival, and characteristics of short- and long-term survivors were assessed. RESULTS: The study included 33 patients. For 16 of the patients, R0 resection margins were achieved. Major postoperative complications (Clavien Dindo ≥ 3A) occurred for 19 patients, and 4 patients experienced postoperative mortality within 90 days. Recurrence occurred for 24 patients. The median overall survival (OS) was 12.8 months (95% confidence interval, 6.5-19.0 months). A 2-year survival period was achieved for 10 patients (30%) and a 5-year survival period for 5 patients (15%). Common bile duct, liver, perineural and perivascular invasion and jaundice were associated with reduced survival. All three recurrence-free patients had R0 resection margins and no liver invasion. CONCLUSION: The median OS after extended resections for advanced GBC was 12.8 months in this cohort. Although postoperative morbidity and mortality were significant, long-term survival (≥ 2 years) was achieved in a subset of patients. Therefore, GBC requiring major surgery does not preclude long-term survival, and a subgroup of patients benefit from surgery.

Long-term survival after hyperthermic intraperitoneal chemotherapy using mitomycin C or oxaliplatin in colorectal cancer patients with synchronous peritoneal metastases: A nationwide comparative study.

OBJECTIVES: In the Netherlands, limited variability exists in performance of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) among centers treating colorectal peritoneal metastases (PM), except for the intraperitoneal drug administration. This offers a unique opportunity to investigate any disparities in survival between the two most frequently used HIPEC regimens worldwide: mitomycin C (MMC) and oxaliplatin. METHODS: This was a comparative, population-based cohort study of all Dutch patients diagnosed with synchronous colorectal PM who underwent CRS-HIPEC between 2014 and 2017. They were retrieved from the Netherlands Cancer Registry. Main outcome was overall survival (OS). The effect of the intraperitoneal drug on OS was investigated using multivariable Cox regression analysis. RESULTS: In total, 297 patients treated between 2014 and 2017 were included. Among them, 177 (59.6%) received MMC and 120 (40.4%) received oxaliplatin. Only primary tumor location was different between the two groups: more left-sided colon in the Oxaliplatin group (47.5% vs. 33.3%, respectively, p=0.048). The 1-, 2- and 3-year OS were 84.6% vs. 85.8%, 61.6% vs. 63.9% and 44.7% vs. 53.5% in patients treated with MMC and oxaliplatin, respectively. Median OS was 30.7 months in the MMC group vs. 46.6 months in the oxaliplatin group (p=0.181). In multivariable analysis, no influence of intraperitoneal drug on survival was observed (adjusted HR 0.77 [0.53-1.13]). CONCLUSIONS: Long-term survival between patients treated with either MMC or oxaliplatin during CRS-HIPEC was not significantly different.

Effect of intraperitoneal chemotherapy concentration on morbidity and survival.

BACKGROUND: Selected patients with colorectal peritoneal metastases are treated with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The concentration of intraperitoneal chemotherapy reflects the administered dose and perfusate volume. The aim of this study was to calculate intraperitoneal chemotherapy concentration during HIPEC and see whether this was related to clinical outcomes. METHODS: An observational multicentre study included consecutive patients with colorectal peritoneal metastases who were treated with CRS-HIPEC between 2010 and 2018 at three Dutch centres. Data were retrieved from prospectively developed databases. Chemotherapy dose and total circulating volumes of carrier solution were used to calculate chemotherapy concentrations. Postoperative complications, disease-free and overall survival were correlated with intraoperative chemotherapy concentrations. Univariable and multivariable logistic regression, Cox regression and survival analyses were performed. RESULTS: Of 320 patients, 220 received intraperitoneal mitomycin C (MMC) and 100 received oxaliplatin. Median perfusate volume for HIPEC was 5·0 (range 0·7-10·0) litres. Median intraperitoneal chemotherapy concentration was 13·3 (range 7·0-76·0) mg/l for MMC and 156·0 (91·9-377·6) mg/l in patients treated with oxaliplatin. Grade III or higher complications occurred in 75 patients (23·4 per cent). Median overall survival was 36·9 (i.q.r. 19·5-62·9) months. Intraperitoneal chemotherapy concentrations were not associated with postoperative complications or survival. CONCLUSION: CRS-HIPEC was performed with a wide variation in intraperitoneal chemotherapy concentrations that were not associated with complications or survival.

ANTECEDENTES: Ciertos pacientes seleccionados con metástasis peritoneales de cáncer colorrectal (peritoneal metastases, PM) se tratan con cirugía citorreductora (cytoreductive surgery, CRS) y quimioterapia intraperitoneal hipertérmica (hyperthermic intraperitoneal chemotherapy, HIPEC). La concentración de quimioterapia intraperitoneal refleja la dosis administrada y el volumen perfundido. El objetivo de este estudio fue calcular la concentración de quimioterapia intraperitoneal durante HIPEC y evaluar si ello se relacionaba con los resultados clínicos. MÉTODOS: Estudio observacional multicéntrico en el que se incluyeron pacientes consecutivos con PM de cáncer colorrectal que fueron tratados con CRS-HIPEC entre 2010 y 2018 en tres centros holandeses. Se obtuvieron los datos a partir de bases de datos mantenidas de forma prospectiva. La dosis de quimioterapia y los volúmenes circulantes totales de solución de perfusión se usaron para calcular las concentraciones de quimioterapia. Las complicaciones postoperatorias y las supervivencias libre de enfermedad y global se correlacionaron con las concentraciones de quimioterapia intraoperatoria. Se realizaron regresiones logísticas univariable y multivariable, regresión de Cox y análisis de supervivencia. RESULTADOS: De 320 pacientes, 220 recibieron mitomicina C intraperitoneal (MMC) y 100 oxaliplatino (OXA). El volumen medio de perfusión para HIPEC fue 5,0 L (rango 0,7-10,0). La mediana de concentración intraperitoneal del agente quimioterápico fue de 13,3 mg/L (rango 7,0-76,0) para MMC y 156,0 mg/L (rango 91,9 - 377,6) en pacientes tratados con OXA. Las complicaciones de grado 3 o mayores ocurrieron en 23,4% (n = 75). La mediana de supervivencia global fue de 36,9 meses (rango intercuartílico 19,5-62,9). Las concentraciones de quimioterapia intraperitoneal no se asociaron con las complicaciones postoperatorias ni con la supervivencia. CONCLUSIÓN: La CRS-HIPEC se realizó con una amplia variación en las concentraciones de quimioterapia intraperitoneal que no se asociaron con las complicaciones ni con la supervivencia.

The diagnostic accuracy of CT and MRI for the detection of lymph node metastases in gallbladder cancer: A systematic review and meta-analysis.

BACKGROUND: Lymph node metastases (LNM) are an ominous prognostic factor in gallbladder cancer (GBC) and, when present, should preclude surgery. However, uncertainty remains regarding the optimal imaging modality for pre-operative detection of LNM and international guidelines vary in their recommendations. The purpose of this study was to systematically review the diagnostic accuracy of computed tomography (CT) versus magnetic resonance imaging (MRI) in the detection of LNM of GBC. METHODS: A literature search of studies published until November 2017 concerning the diagnostic accuracy of CT or MRI regarding the detection of LNM in GBC was performed. Data extraction and risk of bias assessment was performed independently by two reviewers. The sensitivity of CT and MRI in the detection of LNM was reviewed. Additionally, estimated summary sensitivity, specificity and diagnostic accuracy of MRI were calculated in a patient based meta-analysis. RESULTS: Nine studies including 292 patients were included for narrative synthesis and 5 studies including 158 patients were selected for meta-analysis. Sensitivity of CT ranged from 0.25 to 0.93. Estimated summary diagnostic accuracy parameters of MRI were as follows: sensitivity 0.75 (95% CI 0.6 - 0.85), specificity 0.83 (95% CI 0.74 - 0.90), LR + 4.52 (95% CI 2.55-6.48) and LR- 0.3 (95% CI 0.15 - 0.45). Small (<10 mm) LNM were most frequently undetected on pre-operative imaging. Due to a lack of data, no subgroup analysis comparing the diagnostic accuracy of CT versus MRI could be performed. CONCLUSION: The value of current imaging strategies for the pre-operative assessment of nodal status in GBC remains unclear, especially regarding the detection of small LNM. Additional research is warranted in order to establish uniformity in international guidelines, improve pre-operative nodal staging and to prevent futile surgery.

Functional treatment for acute ankle sprains: Softcast wrap versus MOK-cast. A prospective randomized single-center trial.

BACKGROUND: The outcome of a removable (MOK-cast) versus a non-removable polyester wrap for acute lateral ankle ligament injury is unknown. METHODS: Patients with grade II-III lateral ankle ligament injuries were randomized between treatment with a MOK-cast and a wrap. Primary outcome is the Karlsson score for function. Secondary outcomes are patient satisfaction and pain at 4 months follow-up. RESULTS: Randomisation resulted in 53 and 54 patients per arm. Four month follow up was completed by 92% (n=100). The mean Karlsson score improved from 20 to 87 (p<0.01) in the wrap group and 20 to 90 (p<0.01) in the MOK-cast group. In the MOK-cast group treatment satisfaction was higher (8.2 vs 7.8 p 0.04). Reported pain was higher in the first thirty days after injury (p<0.01). CONCLUSIONS: Both wrap and MOK-cast are effective functional treatment options in acute lateral ankle ligament injury. MOK-cast is associated with increased patient satisfaction but higher VAS pain scores. LEVEL OF EVIDENCE: I.

A randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in patients with symptomatic gallstones (SECURE trial protocol).

BACKGROUND: Five to 22 % of the adult Western population has gallstones. Among them, 13 to 22 % become symptomatic during their lifetime. Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. Remarkably, cholecystectomy provides symptom relief in only 60-70 % of patients. The objective of this trial is to compare the effectiveness of usual (operative) care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. DESIGN AND METHODS: The SECURE-trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound proven gallstones or sludge. If patients meet the inclusion criteria they will be randomized to either usual care or the restrictive strategy. Patients in the usual care group will be treated according to the physician's knowledge and preference. Patients in the restrictive care group will be treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy. In this stepwise selection, patients strictly meeting the preselected criteria for symptomatic cholecystolithiasis will be offered a cholecystectomy. Patients not meeting these criteria will be assessed for other diagnoses and re-evaluated at 3-monthly intervals. Follow-up consists of web-based questionnaires at 3, 6, 9 and 12 months. The main end point of this trial is defined as the proportion of patients being pain-free at 12 months follow-up. Pain will be assessed with the Izbicki Pain Score and Gallstone Symptom Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, the association between the patients' symptoms and treatment and work performance, and ultimately, cost-effectiveness. DISCUSSION: The SECURE trial is the first randomized controlled trial examining the effectiveness of usual care versus restrictive care in patients with symptomatic gallstones. The outcome of this trial will inform clinicians whether a more restrictive strategy can minimize persistent pain in post-operative patients at least as good as usual care does, but at a lower cholecystectomy rate. (The Netherlands National Trial Register NTR4022, 17th December 2012) TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022 http://www.zonmw.nl/nl/projecten/project-detail/scrutinizing-inefficient-use-of-cholecystectomy-a-randomized-trial-concerning-variation-in-practi/samenvatting/.

Systematic review of antibiotic treatment for acute calculous cholecystitis.

BACKGROUND: Intravenous antibiotics are frequently used in the initial management of acute calculous cholecystitis (ACC), although supportive care alone preceding delayed elective cholecystectomy may be sufficient. This systematic review assessed the success rate of antibiotics in the treatment of ACC. METHODS: A systematic search of MEDLINE, Embase and Cochrane Library databases was performed. Primary outcomes were the need for emergency intervention and recurrence of ACC after initial non-operative management of ACC. Risk of bias was assessed. Pooled event rates were calculated using a random-effects model. RESULTS: Twelve randomized trials, four prospective and ten retrospective studies were included. Only one trial including 84 patients compared treatment with antibiotics to that with no antibiotics; there was no significant difference between the two groups in terms of length of hospital stay and morbidity. Some 5830 patients with ACC were included, of whom 2997 had early cholecystectomy, 2791 received initial antibiotic treatment, and 42 were treated conservatively. Risk of bias was high in most studies, and all but three studies had a low level of evidence. For randomized studies, pooled event rates were 15 (95 per cent c.i. 10 to 22) per cent for the need for emergency intervention and 10 (5 to 20) per cent for recurrence of ACC. The pooled event rate for both outcomes combined was 20 (13 to 30) per cent. CONCLUSION: Antibiotics are not indicated for the conservative management of ACC or in patients scheduled for cholecystectomy.

Transverse closure of mesenterico-portal vein after vein resection in pancreatoduodenectomy.

BACKGROUND: Resection of the involved mesenteric-portal vein (MPV) is increasingly performed in pancreatoduodenectomy. The primary aim of this study is to assess the rate of R0 resection in transverse closure (TC) versus segmental resection with end-to-end (EE) closure and the secondary aims are to assess the short-term morbidity and long-term survival of TC versus EE. METHODS: Patients undergoing pancreatoduodenectomy with MPV resection were identified from a prospectively database. The reconstruction technique were examined and categorized. Clinical, pathological, short-term and long-term survival outcomes were compared between groups. RESULTS: 110 patients underwent PD with MPV resection of which reconstruction was performed with an end-to-end technique in 92 patients (84%) and transverse closure technique in 18 patients (16%). Patients undergoing transverse closure tended to have had a shorter segment of vein resected (≤2 cm) compared to the end-to-end (83% vs. 43%; P = 0.004) with no difference in R0 rate. Short-term morbidity was similar. The median and 5-year survival was 30.0 months and 18% respectively for patients undergoing transverse closure and 28.6 months and 7% respectively for patients undergoing end-to-end reconstruction (P = 0.766). CONCLUSION: Without compromising the R0 rate, transverse closure to reconstruct the mesenteric-portal vein is shown to be feasible and safe in the setting when a short segment of vein resection is required during pancreatoduodenectomy. Synopsis - We describe a vein closure technique, transverse closure, which avoids the need for a graft, or re-implantation of the splenic vein when resection of the mesenteric-portal vein confluence is required during pancreatoduodenectomy.

Laparoscopy in cholecysto-choledocholithiasis.

Gallstone disease is one of the most common problems in the gastroenterology and is associated with significant morbidity. It may present as stones in the gallbladder (cholecystolithiasis) or in the common bile duct (choledocholithiasis). At the end of the 1980s laparoscopy was introduced and first laparoscopic cholecystectomy was performed in 1985. The laparoscopic technique for removing the gallbladder is the current treatment of choice, although indications for open surgery exist. To perform laparoscopic cholecystectomy as safe as possible multiple safety measures were developed. The gold standard for diagnosing and removing common bile duct stones is Endoscopic Retrograde Cholangiopancreatography (ERCP). The surgical treatment option for choledocholithiasis is laparoscopic cholecystectomy with common bile duct exploration. If experience is not available, than ERCP followed by elective cholecystectomy is by far the best therapeutic modality. The present review will discuss the use, benefits and drawbacks of laparoscopy in patients with cholecystolithiasis and choledocholithiasis.

Partial liver resection because of bile duct injury.

AIM: To analyze the outcome of partial liver resection (PHx) after bile duct injury (BDI) in patients after multimodality treatment. METHODS: Between 1990 and 2012, 800 BDI patients were referred to our tertiary center. Patient characteristics and long-term outcomes were described. RESULTS: PHx was performed in 11 patients (1.4%), mean age 48.3 years (range 29.3-83.5 years), mainly because of complex injury [Amsterdam classification type D (n = 10, 91%), Strasberg type E (n = 7, 64%) and Bismuth type IV (n = 8, 73%)]. In 7 patients (64%), concomitant vasculobiliary injury had occurred in the right hepatic artery (n = 3), proper hepatic artery (n = 1), portal vein (PV; n = 2) and the right hepatic artery and PV simultaneously (n = 1). Early PHx was performed in 2 patients and delayed resection in 9 patients after a median of 57.8 months (range 3.9-183.4 months). The in-hospital mortality was 18% (n = 2) and long-term mortality 9% (n = 1). There were no significant differences in postoperative complications between early and late resection. CONCLUSIONS: Indications for PHx after BDI in patients referred to a tertiary center are relatively low (1.4%) and generally apply to vasculobiliary injury. The implications for treatment are important, so it is worthwhile to classify vascular injuries in the management of BDI.

Radiological criteria for acceptable reduction of extra-articular distal radial fractures are not predictive for patient-reported functional outcome.

The purpose of this study was to assess the association between arm-specific disability measured with the QuickDASH questionaire and radiological criteria in patients with extra-articular distal radial fractures. A consecutive series of 385 patients were initially treated non-operatively for an extra-articular distal radial fracture and 257 (69 %) patients were included in the study. In 203 of these patients (78%) the quality of radiographic reduction was judged to be adequate by radiological parameters, which included dorsal tilt, radial inclination, and radial shortening. In 54 patients (22%) the quality of radiographic alignment was judged to be inadequate. We observed no effect of radiographic parameters on the functional outcome. Female sex and longer duration of follow-up (>35 months) were the only independent prognostic factors significantly associated with a worse QuickDASH score.

Impact of bile duct injury after laparoscopic cholecystectomy on quality of life: a longitudinal study after multidisciplinary treatment.

BACKGROUND AND STUDY AIMS: Bile duct injury (BDI) is associated with increased morbidity and poor survival. The aim of the present study was to compare quality of life (QoL) between patients with BDI and those without after laparoscopic cholecystectomy. A longitudinal assessment was performed and risk factors for poor QoL were determined. PATIENTS AND METHODS: In March 2005 a survey was performed of 403 eligible patients with BDI who were referred to a tertiary center for multidisciplinary treatment by gastroenterologists, radiologists, and surgeons. A longitudinal quality-of-life study was performed to determine changes in outcome after a mean of 5.5 and 11 years' follow-up. RESULTS: Of the eligible 403 patients with BDI, 278 (69 %) responded to the survey after a mean follow-up of 5.9 years. The quality-of-life outcome of injured patients was significantly lower in three of the eight domains compared to patients who underwent cholecystectomy without an injury ( P < 0.05). In seven of the eight QoL domains injured patients scored significantly worse than the healthy population norms ( P < 0.05). The longitudinal assessment after another 5.5 years of follow-up did not show improvement in QoL. Clinical characteristics such as the type of injury and the type of treatment did not affect outcome. Nineteen percent of the patients (n = 53) filed a malpractice claim after BDI. These patients reported better QoL (effect size = 0.6, P = 0.02) when the claim was resolved in their favor than when the claim was rejected. CONCLUSIONS: BDI has a detrimental effect on long-term QoL. QoL in patients with BDI is poor and does not improve during follow-up. The outcome of a malpractice litigation claim is associated with QoL.

[Bile leakage. A performance indicator with markedly different consequences for the patient, specialist and care insurer]. / Gallekkage. Een prestatie-indicator met sterk uiteenlopende consequenties voor patiënt, specialist en zorgverzekeraar.

Bile leakage following laparoscopic cholecystectomy for symptomatic cholelithiasis developed in 3 patients, two women aged 51 and 44, respectively, and a 45-year-old man. The first woman recovered after drainage and was discharged 1 day later. The second woman had persistent symptoms for several months but recovered after invasive examination and restorative surgery. The man died after 2 months of intensive therapy. The Netherlands Healthcare Inspectorate recently published a report on quality of care in Dutch healthcare institutions. Quality of care was assessed on the basis of a set of developed performance indicators, including bile leakage after laparoscopic cholecystectomy. The reported prevalence of bile leakage ranged between 0 and 7%; however, the cause, localisation and severity of the bile leakage and bile-duct injury were not reported. Bile leakage may be used as an indicator to identify hospitals in which this patient population should be analysed in more detail. This analysis could provide more information about the incidence of severe complications (such as bile-duct injury or transection) in order to analyse the quality ofcare. Bile leakage is not directly suitable for the comparison of quality of care by the general population.

[Claims for damages as a result of bile-duct injury during (laparoscopic) cholecystectomy]. / Letselschadeclaims als gevolg van galwegletsel bij een (laparoscopische) cholecystectomie.

OBJECTIVE: To evaluate the frequency of claims for damages initiated by patients referred to a tertiary centre for the treatment of bile-duct injury after a (laparoscopic) cholecystectomy. To determine the relationship between patient characteristics and the initiation of a claim procedure. DESIGN: Descriptive. METHOD: Between 1 January 1990 and 31 December 2005, 500 patients with a bile-duct injury were referred to the Academic Medical Centre, Amsterdam, 454 of whom in the period up to 31 December 2004. Of these, 403 received a mailed questionnaire about the initiation of legal claims for damages. RESULTS: The questionnaire was completed and returned by 278 patients (69%), a representative cohort ofthe 500. Of these, 53 (19%) had submitted a claim for damages. The percentage of claims did not increase over the periods 1991-1995 (19%), 1996-2000 (18%) and 2001-2005 (20%). In the univariate analysis, factors associated with the initiation of a claim procedure were: younger age, the severity of the injury, surgical treatment, being employed at the time of the initial cholecystectomy, and having been placed on sick leave. A complete transection of the common bile duct was the only independent predictive factor for starting a claim procedure (odds ratio: 7.5; 95% CI: 1.9-30.6).

Long-term results of a primary end-to-end anastomosis in peroperative detected bile duct injury.

The management of a bile duct injury detected during laparoscopic cholecystectomy is still under discussion. An end-to-end anastomosis (with or without T-tube drainage) in peroperative detected bile duct injury has been reported to be associated with stricture formation of the anastomosis area and recurrent jaundice. Between 1991 and 2005, 56 of a total of 500 bile duct injury patients were referred for treating complications after a primary end-to-end anastomosis. After referral, 43 (77%) patients were initially treated endoscopically or by percutaneous transhepatic stent placement (n = 3; 5%). After a mean follow-up of 7 +/- 3.3 years, 37 patients (66%) were successfully treated with dilatation and endoscopically placed stents. One patient died due to a treatment-related complication. A total of 18 patients (32%) underwent a hepaticojejunostomy. Postoperative complications occurred in three patients (5%) without hospital mortality. These data confirm that end-to-end anastomosis might be considered as a primary treatment for peroperative detected transection of the bile duct without extensive tissue loss. Complications (stricture or leakage) can be adequately managed by endoscopic or percutaneous drainage the majority of patients (66%) and reconstructive surgery after complicated end-to-end anastomosis is a procedure with relative low morbidity and no mortality.