Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial.

BACKGROUND: Biliary fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic biliary drainage during hepatectomy on the occurrence of postoperative biliary fistula. METHODS: This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of biliary fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The biliary fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The biliary fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing biliary fistula. The use of transcystic drainage during hepatectomy to prevent postoperative biliary fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La fístula biliar es una de las complicaciones más comunes después de la hepatectomía. Este estudio evalúa el efecto del drenaje biliar transcístico durante la hepatectomía en la aparición de una fístula biliar postoperatoria. MÉTODOS: Este ensayo prospectivo aleatorizado y multicéntrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcístico versus grupo control) se llevó a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomía (≥ 2 segmentos) en hígados no cirróticos. El resultado principal fue la aparición de una fístula biliar después de la cirugía. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duración de la estancia hospitalaria, la reintervención, la necesidad de reingreso y las complicaciones causadas por los catéteres. Se realizaron análisis por intención de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intención de tratamiento, 158 pacientes fueron aleatorizados al grupo transcístico y 149 al grupo control. Siete pacientes fueron excluidos del análisis por protocolo por desviaciones del protocolo. La tasa de fístula biliar fue del 5,9% en el análisis por intención de tratamiento y del 6,0% en el análisis por protocolo. Esta tasa fue similar para el grupo transcístico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en términos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duración de la estancia hospitalaria fue mayor para el grupo transcístico (11 versus 10 días, P = 0,042). El riesgo de fístula biliar se correlacionó con el grosor y la longitud de la transección hepática. CONCLUSIÓN: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcístico durante la hepatectomía para prevenir la fístula biliar. No se recomienda el uso de drenaje transcístico durante la hepatectomía para prevenir la fístula biliar postoperatoria.

[Hemihepatectomy]. / Hemihepatektomie.

Hemihepatectomy continues to be a standard procedure for the resection of primary or secondary liver tumours in hepatobiliary surgery. In this tutorial, a case study illustrates the indication for liver resection as well as surgical steps and different techniques. Indications for right or left hemihepatectomy include liver tumours that cause a diffuse or extended infiltration of one half of the liver or tumours extending to the central confluence of liver veins or the liver hilum. Usually, a resection limit is only required in the case of extended hemihepatectomies, where a two-stage resection is needed. In addition to exploration and intraoperative ultrasound, this tutorial presents different entry sites, liver mobilisation, hilum preparation and common techniques of parenchymal dissection. Finally, a number of haemostasis, closure and biliary monitoring techniques are shown. The video tutorial demonstrates all fundamental steps of hemihepatectomy from indication to closure, with a special focus on different approaches.

Pancreaticogastrostomy is superior to pancreaticojejunostomy for prevention of pancreatic fistula after pancreaticoduodenectomy: an updated meta-analysis of randomized controlled trials.

OBJECTIVE: To review prospective randomized controlled trials to determine whether pancreaticogastrostomy (PG) or pancreaticojejunostomy (PJ) is associated with lower risks of mortality and pancreatic fistula after pancreaticoduodenectomy (PD). BACKGROUND: Previous studies comparing reconstruction by PG and PJ reported conflicting results regarding the relative risks of mortality and pancreatic fistula after these procedures. METHODS: MEDLINE, the Cochrane Trials Register, and EMBASE were searched for prospective randomized controlled trials comparing PG and PJ after PD, published up to November 2013. Meta-analysis was performed using Review Manager 5.0. RESULTS: Seven trials were selected, including 562 patients who underwent PG and 559 who underwent PJ. The pancreatic fistula rate was significantly lower in the PG group than in the PJ group (63/562, 11.2% vs 84/559, 18.7%; odds ratio = 0.53; 95% confidence interval, 0.38-0.75; P = 0.0003). The overall mortality rate was 3.7% (18/489) in the PG group and 3.9% (19/487) in the PJ group (P = 0.68). The biliary fistula rate was significantly lower in the PG group than in the PJ group (8/400, 2.0% vs 19/392, 4.8%; odds ratio = 0.42; 95% confidence interval, 0.18-0.93; P = 0.03). CONCLUSIONS: In PD, reconstruction by PG is associated with lower postoperative pancreatic and biliary fistula rates.

Omental flaps reduces complications after pancreaticoduodenectomy.

BACKGROUND: Major complications after pancreaticoduodenectomy are usually caused by a leaking pancreaticojejunal anastomosis. Omental flaps around various anastomoses were used to prevent the formation of fistula. METHODS: We reviewed 147 patients who had undergone pancreaticoduodenectomy between March 2006 and March 2012. The patients were divided into 2 groups according to the application of omental flaps around various anastomoses: group A (101 patients) who underwent omental wrapping procedure; group B (46 patients) who did not undergo the omental wrapping procedure. Perioperative data of the two groups were reviewed to assess the effectiveness of omental flap procedure in the prevention of pancreatic fistula and other complications. RESULTS: No differences were observed in the clinical characteristics between the 2 groups. The incidences of pancreatic fistula (4.0% vs 17.4%), post-pancreatectomy hemorrhage (0 vs 6.5%), biliary fistula (1.0% vs 13.0%), and delayed gastric emptying (4.0% vs 17.4%) were significantly less frequent in group A. The overall morbidity (18.8% vs 47.8%) and hospital stay (8.3 vs 9.6 days) were also significantly lower in group A than in group B. CONCLUSIONS: Omental flaps around various anastomoses after pancreaticoduodenectomy can reduce the incidences of pancreatic fistula, biliary fistula, post-pancreatectomy hemorrhage and delayed gastric emptying. This procedure is simple and effective to reduce the overall morbidity after pancreaticoduodenectomy.

Rubber transcystic drainage reduces the post-removal biliary complications in liver transplantation: a matched case-control study.

PURPOSE: Bile duct (BD) complications continue to be the "Achilles' heel" of liver transplantation, and the utilization of bile duct drainage is still on debate. We describe the results of a less invasive rubber trancystic biliary drainage (TBD) compared to a standard silicone T-tube (TT). METHODS: The transplanted patients (n = 248), over a period of 5 years with a TBD (n = 20), were matched 1:2 with control patients with a TT (n = 40). Primary end points were the overall incidence of BD complications and graft and patient survival. Secondary end points included the complications after the drainage removal. RESULTS: Although the bile duct leakage rates were not significantly different between both groups, the TT group had a significantly higher rate of overall 1-year BD stenosis (40 versus 10 %) (p = 0.036). Three-year patient/graft survival rates were 83.2/80.1 and 84.4/84.4 % for the TT and TBD groups, respectively. The postoperative BD complications, after drainage removal (peritonitis and stenosis), were significantly reduced (p = 0.011) with the use of a TBD. CONCLUSION: The use of rubber TBD in liver transplant recipients does not increase the number of BD complications compared to the T-tube. Furthermore, less BD anastomotic stenosis and post-removal complications were observed in the TBD group compared to the TT group.

Does fibrin glue prevent biliary and pancreatic fistula after surgical resection?

BACKGROUND/AIMS: Efficacy of fibrin glue to prevent biliary or pancreas fistula at the resected edge of the liver or pancreas is controversial. We examined surgical results of fibrin glue use in patients who underwent hepatectomy or pancreatectomy to assess the efficacy of its use. METHODOLOGY: Subjects were divided into two groups; the fibrin glue group in hepatectomy (n=228) and in pancreatectomy (n=113), and the non-fibrin glue group in hepatectomy (n=94) and in pancreatectomy (n=24). In case of hepatectomy, the fibrin glue was sprayed on the cut-surface or anastomotic site of hepatico-jejunostomy. In case of pancreatectomy, the fibrin glue was sprayed on the anastomotic site of pancreato-jejunostomy or closed pancreatic stump. RESULTS: In the hepatectomy group, uncontrolled ascites were more frequent in the fibrin glue group (p<0.05). The use of fibrin glue for both groups has been less frequent in recent years. Prevalence of biliary fistula was not significantly different between groups. Hospital stay in the fibrin glue group was significantly longer than that in the non-fibrin glue group, and was not significantly different between hepatectomy or pancreatectomy groups. There was no significant difference of any complications including pancreatic fistula between groups. Prevalence of pancreatic fistula was not significantly different between the fibrin glue group and the non-fibrin glue group. CONCLUSIONS: Use of fibrin glue did not prevent biliary or pancreatic fistula in patients who underwent hepatectomy and pancreatectomy with or without enteric anastomosis.

[Hepaticojejunostomy after pancreatic head resection - technical aspects for reconstruction of small and fragile bile ducts with T-tube drainage]. / Die Technik der Hepatikojejunostomie mit T-Drainage bei der Rekonstruktion schmalkalibriger Gallengänge nach Pankreaskopfresektion.

BACKGROUND: After pancreatic head resection the reconstruction of small and fragile bile ducts is technically demanding, resulting in more postoperative bile leaks. One option for the reconstruction is the placement of a T-tube drainage at the site of the anastomosis. MATERIAL AND METHODS: Standard reconstruction after pancreatic head resection was an end-to-side hepaticojejunostomy with PDS 5.0, 15-25 cm distally from the pancreaticojejunostomy. For patients with a small bile duct diameter (≤ 5 mm) or a fragile bile duct wall the reconstruction was performed with PDS 6.0 and a T-tube drainage at the side of the anastomosis. RESULTS: The reconstruction with a T-tube drainage at the site of the anastomosis is technically easy to perform and offers the opportunity for immediate visualisation of the anastomosis in the postoperative period by application of water soluble contrast medium. If a bile leak occurs, biliary deviation through the T-tube drainage can enable a conservative management without revisional laparotomy in selected patients. Whether or not a conservative management of postoperative bile leaks will lead to more bile duct strictures is a subject for further investigations. CONCLUSION: A T-tube drainage at the site of the anastomosis can probably not prevent postoperative bile leaks from a difficult hepaticojejunostomy, but in selected patients it offers the opportunity for a conservative management resulting in less re-operations. Therefore we recommend the augmentation of a difficult hepaticojejunostomy with a T-tube drainage.

Role of drain amylase levels assay and routinary postoperative day 3 abdominal CT scan in prevention of complications and management of surgical drains after pancreaticoduodenectomy.

To asses drains amylase (DA) cut-offs for the risk of clinically relevant postoperative pancreatic fistula (POPF) and define the optimal timing of drains removal based on daily DA assay and abdominal CT scan finding after pancreatoduodenectomy (PD). Different algorithms able to identify patients at higher risk of POPF and to assess the optimal time for drains removal after PD have been proposed. The most accurate DA cut-offs in the assessment of the risk of clinically relevant POPF were retrospectively identified. Data from a prospective trial for optimal timing of drains removal were analyzed. Then, to validate the cut-offs identified in the first phase, they were applied to the patients enrolled in the prospective trial. Patients with POD1 DA ≥ 666 U/L were at higher risk of clinically relevant POPF (p 0.0001). POD3 DA value ≥ 252 U/L predicted 88% of clinical relevant fistulas. POD3 DA level ≥ 207 U/L was able to predict 68% of biliary fistulas. Patients with abdominal collection ≥ 5 cm, showed a significantly higher rate (60% vs. 23%, p < 0.001) of biliary fistula. Timing of drains removal did not influence complications. Drains amylase levels predict clinically relevant POPF. Drains should be maintained up to POD3; in case of POD1 DA levels < 666 U/L and POD3 DA levels < 252 U/L drains could be removed. In case of POD3 DA levels, ≥ 207 the routine use of abdominal CT scan in the same day could be justified to detect collections ≥ 5 cm and maintain drains beyond the POD3.

[Prevention and cure of the complications after radical pancreatoduodenectomy].

OBJECTIVE: To investigate the causes and the measures of prevention and cure of the dangerous complications (bleeding, pancreatic fistula, biliary fistula and death) after radical pancreatoduodenectomy (RPD) for periampullary malignant tumor. METHODS: The rate and management of dangerous complications of 156 cases with RPD which were continuous performed by Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology between January 2006 and June 2008 were analyzed retrospectively, including 97 males and 59 females with 37 - 79 years old, the mean age was 56.9 years old. RESULTS: Among the 156 cases with RPD, four patients had massive hemorrhage of gastrointestinal tract due to stress ulcer, two patients had bleeding in the pancreas-intestinal anastomosis after the operation, the rate of postoperative bleeding was 3.9% (6/156). One patient with massive hemorrhage of gastrointestinal tract due to stress ulcer had severe pulmonary infection and ARDS, and died of respiratory failure finally (the overall mortality rate was 0.7%) after ICU for two months. One patients with bleeding in the pancreas-intestinal anastomosis had pancreatic fistula (the rate of pancreatic fistula was 0.7%) 3 days after the second laparotomy to open the jejunum of the pancreas-intestinal anastomosis and make a transfixion of the bleeding points in the stump. Another patient who had the tumor located in the inferior segment of the bile common duct had biliary fistula 11 days after the operation (the rate of biliary fistula was 0.7%). Two patients with fistula had good recovery by expectant treatment of ultrasound-guided puncture and drainage. CONCLUSIONS: Prompt and effective treatment of the complications of bleeding, pancreatic fistula, biliary fistula could maximally decrease the perioperative death rate.

The challenge of pancreatic anastomosis.

BACKGROUND AND AIMS: Significant progress in surgical technique and perioperative management has substantially reduced the mortality rate of pancreatic surgery. However, morbidity remains considerably high, even in expert hands and leakage from the pancreatic stump still accounts for the majority of surgical complications after pancreatic head resection. For that reason, management of the pancreatic remnant after partial pancreatoduodenectomy remains a challenge. This review will focus on technique, pitfalls, and complication management of pancreaticoenteric anastomoses. MATERIALS AND METHODS: A medline search for surgical guidelines, prospective randomized controlled trials, systematic metaanalysis, and clinical reports was performed with regard to surgical technique and complication management of pancreatic anastomoses. RESULTS: Pancreaticojejunostomy appears to be most widely performed, but pancreaticogastrostomy is a reasonable alternative. Postoperative treatment with octreotide can be recommended only for patients with soft pancreatic tissue, and neither stents of the pancreatic duct nor drainages have proven to effectively reduce anastomotic complications. Gastroparesis remains the most common complication after pancreatic surgery and should be treated conservatively. However, it may be a symptom of other local complications, such as anastomotic leakage, pancreatic fistula or abscess. All septic complications may finally result in late postoperative hemorrhage, which requires immediate diagnostic workup and therapy. Today, interventional radiology has emerged as a standard tool in the management of local septic complications and bleeding. Therefore, relaparotomy has become less frequent and salvage pancreatectomy is now a rare procedure in case of local complications. CONCLUSION: The surgeon's experience with one or the other technique of pancreatic anastomosis appears to be more important than the technique itself.

[Prophylaxis and management of biliary complications after orthotopic liver transplantation].

OBJECTIVE: To investigate the risk factors of biliary complications after orthotopic liver transplantation (OLTx) and the relevant prevention and management strategies. METHODS: The clinical data of 368 patients undergoing allograft orthotopic liver transplantation, 282 males and 86 females, aged 47.5 (8 - 73), were collected and analyzed retrospectively. RESULTS: Of the 368 OLTx patients, 36 (9.8%) experienced biliary complications, including simple anastomosis biliary leakage (7 cases), biliary leakage due to injury and omission of accessory hepatic duct (1 case), anastomosis stricture (5 cases), intrahepatic bile duct stricture (3 cases), bile duct stricture secondary to bile duct twist (1 case), calculus of intrahepatic duct (2 cases), bile duct stricture secondary to biliary leakage (2 cases), bile duct stricture combined with intrahepatic biloma (2 cases), bile duct stricture combined with biliary sludge (2 cases), biliary cast syndrome (5 cases), hemobilia (1 case), intrahepatic abscess (3 cases) and Oddi's sphincter dysfunction (2 cases). Among the 36 patients with biliary complications, 23 were cured by nonsurgical therapies; and 13 patients needed abdominal surgical interventions, including retransplantation in 7 cases. CONCLUSION: Biliary complications after OLT are difficult to treat. Most of these complications can be cured conservatively, such as radiological intervention and endoscopic treatment. When the patients are unresponsive to nonsurgical therapies, or when they suffer from hepatic arterial embolism or arterial stricture simultaneously, surgical interventions, even retransplantation should be considered.

The Role of Prophylactic Endoscopic Sphincterotomy for Prevention of Postoperative Bile Leak in Hydatid Liver Disease: A Randomized Controlled Study.

BACKGROUND: Bile leak is the main cause of morbidity and mortality after surgery for hydatid liver cysts. Aim was to assess the role of prophylactic endoscopic sphincterotomy (ES) in reducing postoperative bile leak in patients undergoing partial cystectomy. METHODS: Fifty-four patients with hepatic hydatid cyst met inclusion criteria, 27 were excluded or declined to participate. Twenty-six women and 28 men (mean age 44.6 ± 10.1, range: 22-61 years) were randomly assigned to either group I with ES (n = 27) or group II without ES (n = 27). RESULTS: Demographics and clinical, laboratory, and radiological characteristics of cysts were not statistically different between two groups. Group I had a significant decrease in bile leak rate compared with group II (11.1% versus 40.7%, P = .013), with significantly shorter duration of hospital stay (P < .0001). Biliary fistula in group I had significantly lower daily output (100 mL/day versus 350 mL/day) with gradual reduction till stoppage of leak in 3-4 days without intervention. Biliary fistula in group II had a significantly higher need for biliary intervention through postoperative endoscopic retrograde cholangiopancreatography with ES compared with biliary fistula in group I (FEP = .002), with significantly longer mean time of fistula closure (P = .011) and longer time to drain removal (P < .0001). Nonbiliary complications were comparable between two groups. CONCLUSION: Prophylactic ES provides significant reduction in postoperative bile leak rate with shorter hospital stay after partial cystectomy of hydatid cyst. Biliary fistula in patients with ES has significantly lower daily output with shorter time of drain removal and shorter time to closure than patients without ES.

Occlusion of a Long-Term Transpleural Biliary Drainage Tract Using a Gelatin Pledget (Hep-Plug™).

This case describes a technique used to close a long-term 14F transpleural biliary drainage catheter tract to prevent biliopleural fistula and further complications. We deployed a compressed gelatin foam pledget provided in a pre-loaded delivery device (Hep-Plug™) along the intrahepatic tissue tract for sealing it against the pleural cavity. The device used is easy to handle and gives the Interventional Radiologist the possibility to safely manage and prevent complications after percutaneous transhepatic interventions.

How to improve bilio-stasis in liver surgery.

One of the most fearful complications following hepatic resection is the onset of a biliary fistula. We have attempted to improve intraoperative bilio-stasis to minimize the risk of postoperative fistula development by testing different materials. In the early 2005 we began employing a collagen sponge coated with fibrinogen and thrombin (Tachosil) In our clinical experience, prior to sponge use, a biliary fistula developed in 3.9% of elective resections and 5.1% of surgical procedures for liver trauma. Until now there were no postoperative bile leaks in the patients treated with Tachosil.

Biliary fistula after liver resection: central role of intraoperative perihepatic drain.

BACKGROUNDː Despite notable advances in surgical skills and technology, incidence of biliary fistula after hepatic resection remains an issue. Aim of this study was to assess the role of intraoperative perihepatic drain in diagnosis and treatment of this complication. METHODSː The study included 641 patients who underwent hepatic resection without hepaticojejunostomy between Jan-2003 and Jan-2016. Data were obtained from our single-institution perspective database. RESULTSː Biliary fistula occurred in 3.4% (22/641). Major hepatic resection (P<0.001), S4-involving resection (P=0.006), cholangiocarcinoma (P<0.001) and intraoperative blood losses >375 mL (P<0.001) were associated with biliary fistula. At multivariate analysis, among patients with effective intraoperative perihepatic drain ("D" group) (16/22) onset of biliary fistula (mean, 5.1 vs. 31.5 days, P=0.12) and healing time (mean, 26.5 vs. 82.3 days, P=0.033) were more favorable compared with biloma group (B). Moreover, conservative treatment was more effective in D group (75% of cases). B group developed increased morbidity in terms of jaundice (83.3% vs. 18.7%, P=0.005), abscess (66.7% vs. 6.2%, P=0.003) and a trend of prolonged hospital stay (mean, 25.7 vs. 19.2 days, P=0.51) and mortality (16.7% vs. 6.2%, P=0.449). Difference in biliary fistula severity rate according to ISGLS classification between the two groups was statistically significant (P=0.003). CONCLUSIONSː This study confirms that the wider is the resection the higher the risk for biliary fistula. A correct drainage of bile leakage is the crucial requisite for early healing, providing a milder postoperative course. In our experience, intraoperative perihepatic drain positioning plays a key-role, as well as postoperative patency monitoring.