Success and Safety of Needle Knife Papillotomy and Fistulotomy Based on Papillary Anatomy: A Prospective Controlled Trial.

BACKGROUND: Needle knife papillotomy (NKP) and fistulotomy (NKF) are the two most commonly used rescue techniques for patients with difficult biliary cannulation (DBC). Anatomy of the major duodenal papillae (MDP) influences the optimal precut technique for biliary access. However, comparative studies of the success and safety of NKP and NKF based on the anatomy of MDP have been scarce. METHODS: Patients with intact MDPs for therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) in our center were enrolled. Early needle knife precuts were uniformly applied to patients with DBC. Difficult MDPs were classified into one of five types based on their endoscopic anatomy. Each type of MDP was allocated to NKP or NKF treatment. Patients with types 1 and 2 papillae always received NKF, 3 and 4 received NKP, and 5 could receive either. The safety and efficacy were analyzed between NKP and NKF, and among different types of MDPs. RESULTS: A total of 188 out of 1674 patients undergoing ERCP satisfied the criteria for early precutting: 75 patients were assigned to the NKP group and 113 to the NKF group. The total initial success rate of biliary cannulation (ISRBC) of the precut techniques (both NKP and NKF) for patients with DBC was 91.5%. The ISRBC of patients of the NKP group was similar to that of the NKF group (90.7% vs 92.0%, P > 0.05). The ISRBC of the patients in the swollen MDP subgroup (96.1%) was higher than that of patients in the distorted MDP subgroup (81.8%, P = 0.030). The total and specific complications of the patients of the NKP group were similar to those of the NKF group (P > 0.05). CONCLUSIONS: NKP and NKF, as selected on the basis of MDP anatomy, are equally safe and highly efficient for patients with DBC to allow biliary cannulation. Patients with swollen MDPs had a higher ISRBC than patients with distorted MDPs. Selecting a precut method based on MDP anatomy is an effective and safe strategy for patients with DBC.

Management of biliary diseases after the failure of initial needle knife precut sphincterotomy for biliary cannulation.

Endoscopic retrograde cholangiopancreatography is not always successful even with needle knife precut sphincterotomy (NKPS). How to manage these patients with initial NKPS failure has not been well studied. We report the outcomes of patients who received endoscopic and non-endoscopic rescue treatment after the initial NKPS failure. During the 15 years from 2004 to 2018, 87 patients with initial NKPS failure received interval endoscopic treatment (IET group, n = 43), percutaneous transhepatic biliary drainage (PTBD group, n = 25), or bile duct surgery (BDS group, n = 19) were retrospectively studied. Compared with the PTBD group, the prevalence of choledocholithiasis was higher (69.8% vs. 16.0%, p < 0.001), and malignant bile duct stricture were lower (20.9% vs. 76.0%, p < 0.001) in the IET group. Furthermore, the IET group had a significantly longer time interval between the first and second treatment procedures (4 days vs. 2 days, p = 0.001), a lower technique success rate (79.1% vs. 100%, p = 0.021), and a shorter length of hospital stay (7 days vs. 18 days, p < 0.001). Compared to the BDS group, the only significant finding was that the patients in the IET group were older. Although not statistically significant, the complication rate was lowest in the IET group (7.0%) while highest in the BDS group (15.8%). Complications in the IET group were also mild, as compared with the other two groups. In conclusion, IET should be considered after initial failed NKPS for deep biliary cannulation before contemplating more invasive treatment such as BDS. PTBD may be the alternative therapy for patients with malignant biliary obstruction.

Percutaneous removal of common bile duct stones using a modified balloon technique.

ABSTRACT: To evaluate the effectiveness of percutaneous removal of common bile duct (CBD) stones using a modified balloon technique (balloon catheter sphincteroplasty and expulsion of the stones using half-captured balloons within the sheath) in patients difficult to treat with endoscopy.Fifty patients underwent a modified balloon technique (balloon group), and 53 patients underwent CBD stone removal by the basket method (stone basket group) between 2016 and 2019. We compared the balloon and stone basket groups to evaluate the effectiveness of the modified balloon technique. Outcome variables such as demographics, technical success rates, procedural details, and complications were analyzed. Statistical analysis was performed using Student t test, Fisher exact test, or the χ2 test.The technical success rate in the balloon group was 66% (33/50) in 1 session, 32% (16/50) in 2 sessions, and 2% (1/50) in 3 sessions. That of the stone basket group was 45% (24/53) in 1 session, 38% (20/53) in 2 sessions, and 17% (9/53) in 3 sessions.The total procedure time was significantly shorter in the balloon group (29.5 ±â€Š15.1 minutes) than in the stone basket group (41.7 ±â€Š20.2 minutes) (P < .01), whereas the number of stones was higher in the balloon group than in the stone basket group (P = .03). Maximal stone size, balloon size, pancreatitis, and hospitalization stay did not show statistical differences between the 2 groups. Most complications (9 patients, balloon group; 8 patients, stone basket group) were mild and transient. Major complications occurred in one patient in the stone basket group, who experienced hemobilia due to arterial injury caused by percutaneous transhepatic biliary drainage, which was treated by endovascular embolization without mortality.The modified balloon technique is an effective and safe treatment method for CBD stone removal in patients presenting difficulties in the endoscopic approach.

Goff Septotomy Is a Safe and Effective Salvage Biliary Access Technique Following Failed Cannulation at ERCP.

BACKGROUND: Biliary cannulation is readily achieved in > 85% of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). When standard cannulation techniques fail, salvage techniques utilized include the needle knife precut, double wire technique, and Goff septotomy. METHODS: Records of patients undergoing ERCP from 2005 to 2016 were retrospectively examined using a prospectively maintained endoscopy database. Patients requiring salvage techniques for biliary access were analyzed together with a control sample of 20 randomly selected index ERCPs per study year. Demographic and clinical variables including indications for ERCP, cannulation rates, and adverse events were collected. RESULTS: A total of 7984 patients underwent ERCP from 2005 to 2016. Biliary cannulation was successful in 94.9% of control index ERCPs, 87.2% of patients who underwent Goff septotomy (significantly higher than for all other salvage techniques, p ≤ 0.001), 74.5% of patients in the double wire group and 69.6% of patients in the needle knife precut group. Adverse event rates were similar in the Goff septotomy (4.1%) and index ERCP control sample (2.7%) groups. Adverse events were significantly higher in the needle knife group (27.2%) compared with all other groups. CONCLUSIONS: This study represents the largest study to date of Goff septotomy as a salvage biliary access technique. It confirms the efficacy of Goff septotomy and indicates a safety profile similar to standard cannulation techniques and superior to the widely employed needle knife precut sphincterotomy. Our safety and efficacy data suggest that Goff septotomy should be considered as the primary salvage approach for failed cannulation, with needle knife sphincterotomy restricted to Goff septotomy failures.

Giant stentolith: A rare complication of long-dwelling biliary endoprosthesis.

Endoscopic biliary stenting is performed for various indications in routine clinical practice. Plastic stents are indicated primarily for short-term biliary decompression and require removal or exchange after 12-16 weeks. However, patients who become asymptomatic after the procedure may not return for scheduled stent removal and subsequently present with severe complications. We herein present the case of a 57-year-old female who underwent biliary stenting after the endoscopic clearance of bile duct stones. Her symptoms resolved after the intervention, but she was lost to follow-up with the stent remaining in situ. Four years later, she presented with pain in the right hypochondrium and experienced recurrent episodes of cholangitis. Magnetic resonance cholangiopancreatography revealed a retained plastic stent in the proximal bile duct with a large stone cast around the stent-a stentolith. Owing to the large stone size and proximal migration of the retained biliary stent, the patient required open surgical exploration for stentolith removal. Patients with forgotten biliary stents presenting with serious complications are not uncommon in India. Unaware of the complications of long-dwelling biliary stents, patients ignore the advice for the timely removal of biliary stents. Detailed patient counselling, education and documentation are essential to avoid this condition.

Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

OBJECTIVES: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. METHODS: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. RESULTS: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group. DISCUSSION: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.

Impact of electrical pulse cut mode during endoscopic papillectomy: Pilot randomized clinical trial.

OBJECTIVE: Endoscopic papillectomy is increasingly being used for ampullary adenoma treatment. However, it remains challenging despite increased safety with treatment advances. The ideal power output and electrosurgical current mode for mucosal resection are not established. We aimed to identify the ideal electrical pulse for use during resection. METHODS: This pilot randomized, single-blind, prospective, multicenter trial, recruited patients with ampullary adenomas and conventional anatomy who were scheduled to undergo endoscopic papillectomy. Endoscopic treatment was performed using a standardized algorithm and patients were randomized for endoscopic papillectomy with Endocut or Autocut. The primary outcome was the incidence of delayed bleeding. Incidence of procedure-related pancreatitis, successful complete resection, pathological findings, and other adverse events were secondary endpoints. RESULTS: Sixty patients were enrolled over a 2-year period. The incidences of delayed bleeding (13.3% vs. 16.7%, P = 1.00) and pancreatitis (27% vs. 30%, P = 0.77) were similar between both groups. The rate of crush artifacts was higher in the Endocut than in the Autocut group (27% vs. 3.3%, P = 0.03). Immediate bleeding when resecting tumors greater than 14 mm in diameter was more common in the Autocut than in the Endocut group (88% vs. 46%, P = 0.04). CONCLUSIONS: The Autocut and Endocut modes have similar efficacy and safety for endoscopic papillectomy. The Endocut mode may prevent immediate bleeding in cases with large tumor sizes, although it causes more frequent crush artifacts. REGISTRY AND THE REGISTRATION NUMBER: The Japanese UMIN Clinical Trials Registry (UMIN-CTR: 000021382).

Fully Covered Self-Expandable Metal Stens eliminate surgical repair requirement in both endoscopic sphincterotomy and precut sphincterotomy-related perforation (with video).

OBJECTIVE: Endoscopic retrograde cholangiopancreatography (ERCP)-related perforations occur in 0.3-0.6% of patients. The treatment of retroperitoneal paravaterian perforations (type II), which develop during endoscopic sphincterotomy or precut sphincterotomy, remains a matter of debate. We aimed to evaluate the efficacy of fully covered self expandable metal stent (Fc-SEMS) placement in the treatment of type II perforations. METHODS: The study was conducted in a tertiary ERCP reference center of Turkey between December 2013 and June 2016. Patients with type II ERCP-related perforation constituted the study group. Type II perforations were treated by insertion of an Fc-SEMS (10 mm × 60 mm) during the ERCP procedure or intraoperatively by surgery-endoscopy rendezvous technique, if biliary cannulation could not be achieved. RESULTS: A total of 2689 ERCPs were performed. ERCP-related perforation was observed in 12 procedures (0.4%). Eight patients had Stapfer type II perforations, which developed during endoscopic sphincterotomy in seven patients and precut sphincterotomy in one patient. Fc-SEMSs were inserted during the ERCP procedure in seven patients and intraoperatively by surgery-endoscopy rendezvous technique in one patient. None of the patients developed fever, hemodynamic instability, or peritoneal signs. Stents were removed after a median duration of 9 (3-14) days. All of the patients were uneventfully discharged after an average hospital length of stay of median 5 (1-9) days. CONCLUSION: Fc-SEMSs are highly effective in the nonoperative treatment of type II perforations and their intraoperative insertion in patients with unsuccessful cannulation may facilitate surgery by eliminating the need for duodenum repair surgery.

Use of electrosurgical units in the endoscopic resection of gastrointestinal tumors.

Electrosurgical units (ESUs) are indispensable devices in our endoscopy units. However, many endoscopists are not well-trained on their use and their physical bases are usually not properly studied or understood. In addition, comparative data concerning the settings that may be applied in different circumstances are scarce in the medical literature. Given that it is important to be aware of their strengths and risks, we conducted a review of the available information and research on this topic.

Endoscopic Biliary Intervention Using Traction Devices for Periampullary Diverticulum.

We describe the case a 92-year-old woman who was admitted to our hospital with choledocholithiasis and periampullary diverticulum (PAD). Due to PAD, clear visualization of the ampulla of Vater could not be obtained. Although selective bile duct cannulation was difficult, a 7-Fr plastic stent was placed during the first session. Fifteen days later, endoscopic retrograde cholangiopancreatography was retried using traction devices, and the papilla became visible. Endoscopic sphincterotomy and stone extraction were performed without any complications. The application of traction devices in endoscopic submucosal dissection may be a promising technique in cases in which endoscopic biliary intervention is difficult due to PAD.

Comparison between a rotatable sphincterotome and a conventional sphincterotome for selective bile duct cannulation.

BACKGROUND: Selective biliary cannulation (SBC) is the first challenge of endoscopic retrograde cholangiopancreatography (ERCP), especially for trainees, and a rotatable sphincterotome may be useful to guide the directional axis of the scope and SBC. METHODS: We performed a prospective randomized single-center trial, enrolling 200 patients with a native papilla who required therapeutic biliary ERCP. Patients were randomly assigned to the rotatable sphincterotome group (n = 100) or the conventional sphincterotome group (n = 100). The primary endpoint was successful SBC by the trainees within 10 minutes. RESULTS: The early and late cannulation success rates did not differ significantly between the groups (P = 0.46 and P > 0.99, respectively). For the patients in whom trainees failed to achieve SBC, the rotatable sphincterotome was used as a rescue cannulation technique in four patients from the conventional group; in no patients in the rotatable group was the conventional sphincterotome used for SBC. Post-ERCP pancreatitis (PEP) occurred in 11 patients (5.5 %; 6 mild, 5 moderate); the incidence did not differ significantly between the two groups (rotatable group 3 %, conventional group 8 %; P = 0.21). The two groups were thus combined for evaluation of the factors relating to cannulation difficulty for trainees, which revealed that orientation of the papilla was a significant factor (P < 0.001). CONCLUSIONS: The type of sphincterotome used did not affect the success of SBC by trainees. However, orientation of the papilla was revealed to be a significant factor relating to cannulation difficulty for trainees overall.

Endoscopic Management of Benign Biliary Strictures After Liver Transplantation.

Biliary strictures represent some of the most frequent complications encountered after orthotopic liver transplantation. They comprise an array of biliary abnormalities with variations in anatomical location, clinical presentation, and different pathogenesis. Magnetic resonance cholangiography represents the most accurate noninvasive imaging test that can provide detailed imaging of the whole biliary system-below and above the anastomosis. It is of particular value in those harboring complex hilar or intrahepatic strictures, offering a detailed roadmap for planning therapeutic procedures. Endoscopic therapy of biliary strictures usually requires biliary sphincterotomy plus balloon dilation and stent placement. However, endoscopic management of nonanastomotic biliary strictures is much more complex and challenging as compared with anastomotic biliary strictures. The present article is a narrative review presenting the results of endoscopic treatment of biliary strictures occurring after liver transplantation, describing the different strategies based on the nature of the stricture and summarizing their outcomes.

Management of difficult or failed biliary access in initial ERCP: A review of current literature.

Selective bile duct cannulation is the prerequisite for all endoscopic biliary therapeutic interventions, but this cannot always be achieved easily. Despite advances and new developments in endoscopic accessories, selective biliary access fails in 5%-15% of cases, even in expert high volume centers. Various techniques - such as double-guidewire induced cannulation, pre-cut papillotomy or transpancreatic sphincterotomy with or without placement of a pancreatic stent - have been used to improve cannulation success rates. Repeated and prolonged attempts at cannulation increase the risk of pancreatitis. Repeating the ERCP within a few days after initial failed pre-cut is a successful strategy and should be tried before contemplating more invasive, alternative interventions such as percutaneous-endoscopic or endoscopic ultrasound guided rendezvous procedure, percutaneous transhepatic or surgical intervention. However, standard guidelines or sequential protocol has not been existed up to now. In certain circumstances, there are unique clinical indications for which invasive, alternative interventions should be preferred. We present and discuss the methods that can be used in difficult or failed initial ERCP, therefore to provide practical advice for endoscopists, especially those who are inexperienced.

Usefulness of the 2-Devices-in-1-Channel Method in Case of Difficult Selective Biliary Cannulation Due to Parapapillary Diverticulum/Diverticular Papilla.

PURPOSE: To investigate whether the 2-devices-in-1-channel method is useful for selective biliary cannulation in patients with parapapillary diverticulum or intradiverticular papilla, where the papilla cannot be seen from the front. MATERIALS AND METHODS: Biliary cannulation using the 2-devices-in-1-channel method was performed in 28 patients who presented difficulty due to parapapillary diverticulum or intradiverticular papilla. There were 15 men and 13 women whose mean age was 68.8 (58 to 88) years. There were 22 patients with common bile duct stones, 5 with pancreatic cancer, and 1 with gallbladder cancer. RESULTS: Selective biliary cannulation was successful in all 28 patients. Common bile duct stones could be removed in all 22 patients after endoscopic sphincterotomy or endoscopic balloon dilation, and all 5 patients with pancreatic cancer as well as the patient with gallbladder cancer were successfully drained. There were no procedure-related complications. CONCLUSIONS: From these results, we consider the 2-devices-in-1-channel method is useful and safe to perform selective biliary cannulation when the papilla cannot be seen from the front due to parapapillary diverticulum, or intradiverticular papilla.

Is the Isolated-Tip Needle-Knife Precut as Effective as Conventional Precut Fistulotomy in Difficult Biliary Cannulation?

Background/Aims: Needle-knife precut fistulotomy (NK-F) is a well-known freehand technique for difficult biliary cannulation (DBC). Another approach involves the use of Iso-Tome®, a modified precutting device with an insulated needle tip to prevent direct thermal injury. This comparative study aimed to evaluate the efficacy of the Iso-Tome® precut (IT-P) compared to that of NK-F for DBC. Methods: Patients with a naïve papilla who underwent early IT-P or NK-F for DBC were enrolled. DBC was defined as failure to achieve selective biliary access by wire-guided cannulation despite 5 minutes of attempted cannulation, ≥5 papillary contacts, or a hooknose-shaped papilla. The primary endpoint was the primary technical success rate, which was based on a noninferiority model. Results: A total of 239 DBC cases were enrolled. The primary technical success rates were 74.7% (89/119) in the IT-P group and 91.6% (110/120) in the NK-F group (lower limit of 90% confidence interval, -0.23; p=0.927 for a noninferiority margin of 10%). The total technical success rates were 87.4% and 95.0%, respectively (p=0.038). The mean precutting times for successful biliary access were 11.2 minutes for IT-P and 7.3 minutes for NK-F (p<0.01). The procedure-related adverse event rates were 9.2% for IT-P and 5.8% for NK-F (p=0.318). The rates of post-endoscopic retrograde cholangiopancreatography pancreatitis were 4.2% and 2.5%, respectively (p=0.499). Conclusions: IT-P failed to exhibit noninferiority compared with NK-F regarding the primary technical success rate of DBC, but there was no difference in the frequency of adverse events.

Successful endoscopic management of a persistent bronchobiliary fistula with Histoacryl®/Lipiodol® mixture.

Introduction A bronchobiliary fistula (BBF) following liver directed therapy (resection/ablation) is a rare complication in which an abnormal communication between the biliary tract and bronchial tree is formed. This case report describes the successful management of a persistent BBF following multiple liver wedge resections and microwave ablation in a patient with a metastatic neuroendocrine tumour of the terminal ileum. Case history A 69-year-old man presented with unexplained weight loss and was subsequently diagnosed with a neuroendocrine tumour of the terminal ileum and liver metastasis. Following elective right hemicolectomy and multiple bilobar liver wedge resections combined with liver microwave ablation, he developed an early bile leak. A month later, a right subphrenic collection was identified and four months following surgery, biloptysis was noted. Numerous attempts with endoscopic retrograde biliary drainage (ERBD) failed to achieve sufficient drainage. The patient was treated successfully with endoscopic injection of a mixture of Histoacryl® glue (B Braun, Sheffield, UK) and Lipiodol® (Guerbet, Solihull, UK). There was no evidence of the BBF one year following intervention. Conclusions This novel approach for persistent BBF management using endoscopic Histoacryl® glue embolisation of the fistula tract should be considered either as an adjunct to ERBD or when biliary tract decompression by drainage and/or sphincterotomy fails, prior to proceeding with surgical interventions.

"Post-cut": An endoscopic technique for managing impacted biliary stone within an entrapped extraction basket.

BACKGROUND AND STUDY AIMS: Ampullary impaction of an entrapped stone-basket complex is not an infrequent yet challenging event during endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study is to evaluate the feasibility, safety, and efficacy of "post-cut" for the management of such scenarios. PATIENTS AND METHODS: Patients with impacted biliary stone with an entrapped basket during ERCP at West China Hospital, Chengdu, China, from October 2004 to August 2014 were included in this retrospective study. Adequate biliary sphincterotomy was performed in all cases before attempted stone basket removal. Using free hand needle knife techniques, the authors extended the sphincterotomy along the long axis of the distal common bile duct to manage the biliary stone-basket impaction. In comparison with "pre-cut", the authors coined the term "post-cut" referring to this technique. The feasibility, safety, and potential complications of post-cut were analysed. RESULTS: "Post-cut" was performed in consecutive 10 cases of impacted biliary stone within an entrapped extraction basket. The size of the removed stone ranged from 6 mm to 13 mm. The length of post-cut is 2 mm to 4 mm. The impacted basket was easily retrieved in all patients without complications, including bleeding, perforation, and pancreatitis. CONCLUSION: "Post-cut" is a feasible, effective, and safe endoscopic technique when impaction of a biliary stone with an entrapped extraction basket develops.