Superiority of Step-up Approach vs Open Necrosectomy in Long-term Follow-up of Patients With Necrotizing Pancreatitis.

BACKGROUND & AIMS: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. METHODS: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores. RESULTS: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups. CONCLUSIONS: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.

Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial.

BACKGROUND: Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS: In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711. FINDINGS: Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62-1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53-3·59, p=0·50), nor did any of the major complications included in the primary endpoint. INTERPRETATION: In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference. FUNDING: The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.

Characterization and treatment of persistent hepatocellular secretory failure.

BACKGROUND & AIMS: Hepatocellular secretory failure induced by drugs, toxins or transient biliary obstruction may sometimes persist for months after removal of the initiating factor and may then be fatal without liver transplantation. We characterized patients with severe persistent hepatocellular secretory failure (PHSF) and treated them with the pregnane X receptor (PXR) agonist, rifampicin. We also studied the effect of rifampicin on PXR-dependent expression of genes involved in biotransformation and secretion in vitro. METHODS: Thirteen patients (age 18-81 years, 6 male) with hepatocellular secretory failure that persisted after removal of the inducing factor (drugs/toxin: 9) or biliary obstruction (4) were identified over 6 years. Six of these patients were screened for ATP8B1 or ABCB11 mutations. All were treated with rifampicin (300 mg daily) for 1-10 weeks. Expression of genes involved in biotransformation and secretion was determined by rtPCR in human hepatocytes and intestinal cells incubated with rifampicin (10 µmol/L). RESULTS: Serum bilirubin of patients with PHSF ranged from 264 to 755 µmol/L. Normal γGT was found in 10/13 patients of whom 3/6 tested positive for ATP8B1/ABCB11 mutations. Serum bilirubin declined to <33 µmol/L after 1-10 weeks of rifampicin treatment. In vitro, rifampicin PXR-dependently upregulated biotransformation phase 1 (CYP3A4), phase 2 (UGT1A1) and phase 3 (MRP2) enzymes/carriers as well as the basolateral bile salt exporter OSTß. CONCLUSION: Persistent hepatocellular secretory failure may develop in carriers of transporter gene mutations. In severe cases, rifampicin may represent an effective therapeutic option of PHSF. PXR-dependent induction of CYP3A4, UGT1A1, MRP2 and OSTß could contribute to the anticholestatic effect of rifampicin in PHSF.

Imaging of perihilar cholangiocarcinoma.

OBJECTIVE: The purpose of this article is to review imaging workup of perihilar cholangiocarcinoma, including MDCT and MRI protocols, imaging findings, differential diagnosis, and staging. A reporting template is included. CONCLUSION: Imaging plays a central role in the detection, differential diagnosis, and staging of perihilar cholangiocarcinoma.

Percutaneous treatment of common bile duct stones: results and complications in 110 consecutive patients.

BACKGROUND/AIMS: Choledocholithiasis is a common complication of cholecystolithiasis, occurring in 15-20% of patients who have gallbladder stones. Endoscopic retrograde cholangio-pancreatography is the standard treatment. When this is not possible or not feasible, percutaneous transhepatic stone removal is an alternative treatment. In this retrospective study, we analyze 110 patients who were treated with percutaneous transhepatic removal of Common Bile Duct (CBD) stones. PATIENTS AND METHODS: Between March 1998 and September 2013 110 patients (61 men, 49 women; aged 14-96, mean age 69.7 years) with confirmed bile duct stones were included. PTC was done using ultrasound and fluoroscopy. Balloon dilatation of the papilla was done with 8-12 mm balloons. If stone size exceeded 10 mm, mechanical lithotripsy was performed. Stones were then removed by percutaneous extraction or evacuation into the duodenum. RESULTS: In 104 patients (104/110; 94.5%) total stone clearance of the CBD was achieved. A total of 12 complications occurred (10.9%), graded with the Clavien-Dindo scale as IVa, IVb, and V, respectively; hypoxia requiring resuscitation, sepsis and death due to ongoing cholangiosepsis (n = 1, 4, 1). Minor complications I, II, and IIIa included: small liver abscess, pleural empyema, transient hemobilia and mild fever (n = 1, 1, 2, 2). CONCLUSION: Percutaneous removal of CBD stones is an effective alternative treatment, when endoscopic treatment is contra-indicated, fails or is not feasible. It is effective, has a low complication rate and using deep sedation potentially requires only a very limited number of treatment sessions.

Leukemia and brain tumors among children after radiation exposure from CT scans: design and methodological opportunities of the Dutch Pediatric CT Study.

Computed tomography (CT) scans are indispensable in modern medicine; however, the spectacular rise in global use coupled with relatively high doses of ionizing radiation per examination have raised radiation protection concerns. Children are of particular concern because they are more sensitive to radiation-induced cancer compared with adults and have a long lifespan to express harmful effects which may offset clinical benefits of performing a scan. This paper describes the design and methodology of a nationwide study, the Dutch Pediatric CT Study, regarding risk of leukemia and brain tumors in children after radiation exposure from CT scans. It is a retrospective record-linkage cohort study with an expected number of 100,000 children who received at least one electronically archived CT scan covering the calendar period since the introduction of digital archiving until 2012. Information on all archived CT scans of these children will be obtained, including date of examination, scanned body part and radiologist's report, as well as the machine settings required for organ dose estimation. We will obtain cancer incidence by record linkage with external databases. In this article, we describe several approaches to the collection of data on archived CT scans, the estimation of radiation doses and the assessment of confounding. The proposed approaches provide useful strategies for data collection and confounder assessment for general retrospective record-linkage studies, particular those using hospital databases on radiological procedures for the assessment of exposure to ionizing or non-ionizing radiation.

A step-up approach or open necrosectomy for necrotizing pancreatitis.

BACKGROUND: Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach. METHODS: In this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death. RESULTS: The primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P=0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P=0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P=0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P=0.03) and new-onset diabetes (16% vs. 38%, P=0.02). CONCLUSIONS: A minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)

Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711].

BACKGROUND: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS/DESIGN: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs. DISCUSSION: The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.

Short-term effects of combined hepatic vein embolization and portal vein embolization for the induction of liver regeneration in a rabbit model.

PURPOSE: Alternative methods to optimize the hypertrophy response after portal vein embolization (PVE) are desired. This study assessed the effect of hepatic vein embolization (HVE) in addition to PVE on liver hypertrophy response in a standardized rabbit model. MATERIALS AND METHODS: Thirty rabbits were allocated to groups according to intervention: PVE alone, HVE alone, and a combination of HVE and PVE. The liver regeneration response of the nonembolized, caudal liver was assessed by computed tomographic volumetry, liver-to-body weight index, and the amount of proliferating hepatocytes. RESULTS: The caudal liver volume (CLV) increased significantly more in the PVE and combined PVE/HVE group than in the HVE group at 3 and 7 days after the procedure (P < .01). There were no significant differences in CLV increase or degree of hypertrophy between the PVE and combined embolization groups. The caudal liver-to-body weight index was significantly higher in the PVE and combined embolization groups than in the HVE group on day 7 (P < .01). The index was also significantly higher in the combined PVE/HVE group compared with the PVE group (P = .008). The caudal liver tissue of the PVE and combined groups contained a significantly higher number of proliferating hepatocytes compared with the HVE group on day 7 (P < .01). CONCLUSIONS: Although histologic and additional regenerative changes are seen, HVE in addition to PVE has no additional short-term effect on hypertrophy response. The combination of HVE and PVE may therefore have little use in a clinical setting.

Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis.

BACKGROUND: For patients with chronic pancreatitis and a dilated pancreatic duct, ductal decompression is recommended. We conducted a randomized trial to compare endoscopic and surgical drainage of the pancreatic duct. METHODS: All symptomatic patients with chronic pancreatitis and a distal obstruction of the pancreatic duct but without an inflammatory mass were eligible for the study. We randomly assigned patients to undergo endoscopic transampullary drainage of the pancreatic duct or operative pancreaticojejunostomy. The primary end point was the average Izbicki pain score during 2 years of follow-up. The secondary end points were pain relief at the end of follow-up, physical and mental health, morbidity, mortality, length of hospital stay, number of procedures undergone, and changes in pancreatic function. RESULTS: Thirty-nine patients underwent randomization: 19 to endoscopic treatment (16 of whom underwent lithotripsy) and 20 to operative pancreaticojejunostomy. During the 24 months of follow-up, patients who underwent surgery, as compared with those who were treated endoscopically, had lower Izbicki pain scores (25 vs. 51, P<0.001) and better physical health summary scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey questionnaire (P=0.003). At the end of follow-up, complete or partial pain relief was achieved in 32% of patients assigned to endoscopic drainage as compared with 75% of patients assigned to surgical drainage (P=0.007). Rates of complications, length of hospital stay, and changes in pancreatic function were similar in the two treatment groups, but patients receiving endoscopic treatment required more procedures than did patients in the surgery group (a median of eight vs. three, P<0.001). CONCLUSIONS: Surgical drainage of the pancreatic duct was more effective than endoscopic treatment in patients with obstruction of the pancreatic duct due to chronic pancreatitis. (Current Controlled Trials number, ISRCTN04572410 [controlled-trials.com].).

Describing peripancreatic collections in severe acute pancreatitis using morphologic terms: an international interobserver agreement study.

BACKGROUND/AIMS: The current terminology for describing peripancreatic collections in acute pancreatitis (AP) derived from the Atlanta Symposium (e.g. pseudocyst, pancreatic abscess) has shown a very poor interobserver agreement, creating the potential for patient mismanagement. A study was undertaken to determine the interobserver agreement for a new set of morphologic terms to describe peripancreatic collections in AP. METHODS: An international, interobserver agreement study was performed: 7 gastrointestinal surgeons, 2 gastroenterologists and 8 radiologists in 3 US and 5 European tertiary referral hospitals independently evaluated 55 computed tomography (CT) scans of patients with predicted severe AP. The percentage agreement [median, interquartile range (IQR)] for 9 clinically relevant morphologic terms was calculated among all reviewers, and separately among radiologists and clinicians. The percentage agreement was defined as poor (<0.50), moderate (0.51-0.70), good (0.71-0.90), and excellent (0.91-1.00). RESULTS: Overall agreement was good to excellent for the terms collection (percentage agreement = 1; IQR 0.68-1), relation with pancreas (1; 0.68-1), content (0.88; 0.87-1), shape (1; 0.78-1), mass effect (0.78; 0.62-1), loculated gas bubbles (1; 1-1), and air-fluid levels (1; 1-1). Overall agreement was moderate for extent of pancreatic nonenhancement (0.60; 0.46-0.88) and encapsulation (0.56; 0.48-0.69). The percentage agreement was greater among radiologists than clinicians for extent of pancreatic nonenhancement (0.75 vs. 0.57, p = 0.008), encapsulation (0.67 vs. 0.46, p = 0.001), and content (1 vs. 0.78, p = 0.008). CONCLUSION: Interobserver agreement for the new set of morphologic terms to describe peripancreatic collections in AP is good to excellent. Therefore, we recommend that current clinically based definitions for CT findings in AP (e.g. pancreatic abscess) should no longer be used.

Controversies in the use of portal vein embolization.

BACKGROUND/AIMS: Portal vein embolization (PVE) has reached worldwide acceptance to increase future remnant liver (FRL) volume before undertaking major liver resection. The aim of this overview is to point out and discuss current controversies in the application of PVE. METHODS: Review of literature pertaining to techniques of PVE, complications, tumor proliferation, timing of resection, and hypertrophy response after PVE. RESULTS: Procedure-related complications after PVE include hematoma, hemobilia, overflow of embolization material, and thrombosis of portal vein branch(es) of the non-embolized lobe. Persistence of the embolized, atrophic lobe is usually not harmful. Embolization of the portal branches to segment 4 in addition to embolization of the right portal trunk is controversial and is advised only in selected cases. It remains undecided whether embolization of the portal venous system is more effective in inducing hypertrophy of the FRL than ligation of the portal vein. Accelerated tumor growth after PVE is a major concern and requires consideration of post-PVE chemotherapy. A waiting time of 3 weeks between PVE and liver resection is advised. Post-hepatectomy regeneration is not hampered after preoperative PVE. CONCLUSION: PVE is a useful preoperative intervention to increase volume and function of the FRL. Further progress awaits clarification of the mechanisms of the hypertrophy response induced by PVE in conjunction with new embolization materials and protective chemotherapy.

Survival in bile duct injury patients after laparoscopic cholecystectomy: a multidisciplinary approach of gastroenterologists, radiologists, and surgeons.

BACKGROUND: Bile duct injury (BDI) after laparoscopic cholecystectomy (LC) has an enormous socioeconomic impact on patients. BDI has been associated with severe morbidity, impaired survival, and poor long-term quality of life. This study was performed to analyze the impact of a multidisciplinary approach in BDI patients on survival. METHODS: A prospective cohort study was performed in a tertiary referral center to determine the effect of a multidisciplinary treatment on survival in 500 bile duct injury patients. Referral pattern and patient survival after bile duct injury are analyzed, and a survey was performed on the prevalence of medical litigation in bile duct injury patients. RESULTS: The number of patients referred to the Amsterdam Medical Center increased to 0.3% of the total number of patients, yearly undergoing laparoscopic cholecystectomy in the Netherlands. The referral rate to the departments of gastroenterology (n = 329), surgery (n = 146), and radiology (n = 25) was, respectively, 66%, 29%, and 5%. After referral to the tertiary center, 150 patients (30%) were internally referred to a different department to optimize treatment. The 10-year survival rate in bile duct injury patients is not significantly worse compared with the age-matched general Dutch population (89% vs 88%, P = .7). Overall, 19% of the patients submitted a medical litigation claim against the initial surgeon or hospital. In total, 40% of these claims were resolved in the favor of the patients through settlement or verdict. CONCLUSIONS: BDI is a severe complication in modern surgical practice. BDI is associated with major morbidity and high rates of litigation claims. The detrimental effect of BDI on survival can be prevented if gastroenterologists, radiologists, and surgeons work together in a multidisciplinary team.

Results of percutaneous sclerotherapy and surgical treatment in patients with symptomatic simple liver cysts and polycystic liver disease.

AIM: To evaluate the results of the treatment of simple liver cysts (solitary and multiple) and polycystic liver disease (PLD) using percutaneous sclerotherapy and/or surgical procedures in a single tertiary referral centre. METHODS: Retrospective analysis of 54 patients referred for evaluation and possible treatment of simple liver cysts (solitary and multiple) and PLD, from January 1997 to July 2006. RESULTS: Simple liver cysts were treated in 41 pts (76%) with a mean size of 12.6 cm. The most common reason for referral was abdominal pain or discomfort (85%). Percutaneous sclerotherapy was performed as initial treatment in 30 pts, showing cyst recurrence in 6 pts (20%). Surgical treatment was initially performed in 11 pts with cyst recurrence in 3 pts (27%). PLD was treated in 13 pts (24%) with a mean size of the dominant cyst of 13 cm. Percutaneous sclerotherapy for PLD was performed in 9 pts with recurrence in 7 pts (77.8%). Surgical treatment for PLD was undertaken in 4 pts (30.8%) with recurrence in all. Eventually, 2 pts with PLD in the presence of polycystic kidney disease underwent liver- and kidney transplantation because of deterioration of liver and kidney function. CONCLUSION: The majority of patients with simple liver cysts and PLD are referred for progressive abdominal pain. As initial treatment, percutaneous sclerotherapy is appropriate. Surgical deroofing is indicated in case of cyst recurrence after percutaneous sclerotherapy. However, the results of percutaneous sclerotherapy and surgical treatment for PLD are disappointing. Partial liver resection is indicated when there is suspicion of a pre-malignant lesion.

Describing Peripancreatic Collections According to the Revised Atlanta Classification of Acute Pancreatitis: An International Interobserver Agreement Study.

OBJECTIVES: Severe acute pancreatitis is associated with peripancreatic morphologic changes as seen on imaging. Uniform communication regarding these morphologic findings is crucial for accurate diagnosis and treatment. For the original 1992 Atlanta classification, interobserver agreement is poor. We hypothesized that for the revised Atlanta classification, interobserver agreement will be better. METHODS: An international, interobserver agreement study was performed among expert and nonexpert radiologists (n = 14), surgeons (n = 15), and gastroenterologists (n = 8). Representative computed tomographies of all stages of acute pancreatitis were selected from 55 patients and were assessed according to the revised Atlanta classification. The interobserver agreement was calculated among all reviewers and subgroups, that is, expert and nonexpert reviewers; interobserver agreement was defined as poor (≤0.20), fair (0.21-0.40), moderate (0.41-0.60), good (0.61-0.80), or very good (0.81-1.00). RESULTS: Interobserver agreement among all reviewers was good (0.75 [standard deviation, 0.21]) for describing the type of acute pancreatitis and good (0.62 [standard deviation, 0.19]) for the type of peripancreatic collection. Expert radiologists showed the best and nonexpert clinicians the lowest interobserver agreement. CONCLUSIONS: Interobserver agreement was good for the revised Atlanta classification, supporting the importance for widespread adaption of this revised classification for clinical and research communications.

Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868].

BACKGROUND: The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. METHODS/DESIGN: 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. DISCUSSION: The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.

Incidence and management of biliary leakage after hepaticojejunostomy.

This study analyzes the change in the management of biliary leakage after hepaticojejunostomy. Between 1993 and 2003 all patients (n = 1033) were studied with a hepaticojejunostomy as part of a pancreatoduodenectomy (n = 486), proximal bile duct resection (without liver resection) (n = 35), and biliodigestive bypass for malignant (n = 302) and benign (n = 210) disease. Biliary leakage was defined as the presence of bile-stained fluid (>50 mL) in the abdominal drain more than 24 hours after surgery, proven radiologically or at relaparotomy. The studied patients were divided into two equal periods to analyze the change in management. Overall, 24 of 1033 patients (2.3%) had biliary leakage. In multivariate analysis, a body mass index greater than 35 kg/m2 (P = .012), endoscopic biliary drainage (P = .044), and an anastomosis on the segmental bile ducts (P < .001) were independent predictors of leakage. Management in the first half of the study period (1993-1998) versus the second half (1999-2003) was maintenance of operatively placed drains (18% vs. 15%, respectively, P = 1.000), percutaneous transhepatic biliary drainage (18% vs. 69%, respectively, P = .012), surgical drainage (55% vs. 8%, respectively, P = .023), and re-hepaticojejunostomy (9% vs. 8%, respectively, P = 1.000). There was no mortality in the patients with biliary leakage. Leakage after a hepaticojejunostomy is a relatively rare complication without mortality and can safely be managed with percutaneous transhepatic biliary drainage.

Percutaneous balloon dilatation and long-term drainage as treatment of anastomotic and nonanastomotic benign biliary strictures.

PURPOSE: This study was designed to determine the effectiveness of percutaneous balloon dilation and long-term drainage of postoperative benign biliary strictures. METHODS: Medical records of patients with postoperative benign biliary strictures, in whom percutaneous transhepatic biliary drainage (PTBD) and balloon dilation was performed between January 1999 and December 2011, were retrospectively reviewed. PTBD and balloon dilation (4-10 mm) were followed by placement of internal-external biliary drainage catheters (8.5-12 F). Patients were scheduled for elective tube changes, if necessary combined with repeated balloon dilation of the stenosis, at 3-week intervals up to a minimum of 3 months. RESULTS: Ninety-eight patients received a total of 134 treatments. The treatment was considered technically successful in 98.5%. Drainage catheters were left in with a median duration of 14 weeks. Complications occurred in 11 patients. In 13 patients, percutaneous treatment was converted to surgical intervention. Of 85 patients in whom percutaneous treatment was completed, 11.8% developed clinically relevant restenosis. Median follow-up was 35 months. Probability of patency at 1, 2, 5, and 10 years was 0.95, 0.92, 0.88, and 0.72, respectively. Overall, 76.5% had successful management with PTBD. Restenosis and treatment failure occurred more often in patients who underwent multiple treatments. Treatments failed more often in patients with multiple strictures. All blood markers of liver function significantly decreased to normal values. CONCLUSIONS: Percutaneous balloon dilation and long-term drainage demonstrate good short- and long-term effectiveness as treatment for postoperative benign biliary strictures with an acceptably low complication rate and therefore are indicated as treatment of choice.

[Jaundice and a pancreatic tumour caused by auto-immune pancreatitis]. / Auto-immune pancreatitis als oorzaak van geelzucht en een tumor in het pancreas.

Three male patients aged between 50 and 70 years were referred with jaundice and weight loss. Imaging showed a pancreatic mass and changes in the calibre of the choledochal or pancreatic duct, suggestive of malignancy. Two patients were operated on. One patient was considered to have an unresectable carcinoma but showed remarkable clinical improvement after steroids were given for his poor condition. In the other patient a resection was performed. Histology showed IgG4-positive plasma cell infiltration without signs of malignancy. Eventually these patients were diagnosed with auto-immune pancreatitis (AIP). In the third patient AIP was considered beforehand and this patient was treated with steroids. He responded quickly both clinically and radiologically. CT imaging showed complete remission of the mass. AIP is a benign inflammatory process which can mimic pancreatic carcinoma. In doubtful cases, a short trial of steroids might be considered.