Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial.

BACKGROUND AND AIMS: The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs. METHODS: This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful. RESULTS: Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P = 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P = 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P = .34). No differences were detected in rates of adverse events. CONCLUSIONS: This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.

Cholangioscopy- versus fluoroscopy-guided transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a prospective randomized crossover study.

BACKGROUND: To evaluate the lateral extent of extrahepatic cholangiocarcinoma, the value of cholangioscopy-guided mapping biopsy (CMB) compared with that of fluoroscopy-guided mapping biopsy (FMB) remains unknown. The aim of this study was to compare these two techniques. METHODS: In this prospective, randomized, crossover study, both CMB and FMB techniques were performed for all patients in a randomized order. Target sites for the mapping biopsy were determined based on resection lines of possible surgical procedures. At least two biopsy strokes were attempted at each target site. The primary outcome was the rate of site-based successful biopsies, which was defined as acquisition of epithelium-containing material appropriate for diagnosing benignancy/malignancy from each site, regardless of amount of materials obtained from the same site. RESULTS: Between September 2016 and October 2018, 28 patients (16 distal bile duct cancer and 12 perihilar bile duct cancer) were enrolled and divided into two groups of 14 patients: CMB first and FMB first. Although all 118 target sites could be approached using CMB, FMB forceps reached only 71% of them with significantly poor accessibility to the B2/3 confluence. Since several materials were too small and did not contain epithelium, the overall rates of site-based successful biopsies were 78% (92/118) using CMB and 64% (76/118) using FMB (P = 0.031). CONCLUSIONS: The rate of site-based successful biopsies using CMB was significantly higher than that using FMB when evaluated using specimens obtained from several biopsy strokes.

Value of repeated cytology for intraductal papillary mucinous neoplasms of the pancreas with high risk potential of malignancy: Is it a promising method for monitoring a malignant transformation?

OBJECTIVES: The efficacy of and indications for cytological reexamination to detect malignant changes in branch duct type intraductal papillary mucinous neoplasms (BD-IPMNs) have not been studied in detail. We conducted a retrospective study to evaluate the efficacy and indications of cytological reexamination by using pancreatic juice (repeated cytology) for BD-IPMNs. METHODS: Forty-five patients who underwent repeated cytology after a diagnosis of benignancy by using initial cytology were recruited for this study. RESULTS: Thirty-eight patients, excluding 7 patients with lack of surveillance period after the final cytology, were classified into Malignancy (n = 13) and Benignancy groups (n = 25) on the bases of the findings from resected specimens or changes in BD-IPMNs after repeated cytology. The sensitivity and specificity to detect malignant changes in BD-IPMNs by using repeated cytology were 62% and 100%, respectively. For the 12 patients with mural nodules (MNs) ≥ 5 mm (67% of them were malignant), the sensitivity was 50%, whereas, for the 26 patients without MNs ≥ 5 mm (19% of them were malignant), it was 80%. In addition, malignant changes in BD-IPMNs after initial cytology occurred in 62% of the patients with changes in the MNs and 27% of the patients with an increase in the cyst size. CONCLUSION: Repeated cytology can play a role in the determination for surgery even after a diagnosis of benignancy by using initial cytology, especially for BD-IPMNs without MNs ≥5 mm. In addition, changes in the MNs or cyst size may be appropriate indications for repeated cytology.

Efficacy of EUS-guided celiac plexus neurolysis compared with medication alone for unresectable pancreatic cancer in the oxycodone/fentanyl era: a prospective randomized control study.

BACKGROUND AND AIMS: The efficacy of celiac plexus neurolysis (CPN) with EUS guidance (EUS-CPN) has not been confirmed in the era of developed opioids. The aim of this study was to evaluate the efficacy of EUS-CPN for patients with pancreatic cancer-associated pain to compare medication using oxycodone and/or fentanyl with and without EUS-CPN. METHODS: In this randomized control study involving patients who underwent EUS-CPN and those who did not, pain, quality of life (QOL), and opioid consumption were compared. Standard medicinal treatment using oxycodone and/or fentanyl was performed for both groups. The primary endpoint was defined as the pain evaluated by using a visual analog scale (VAS) rated from a 0 to 10, 4 weeks after the baseline. RESULTS: For 48 registered patients, the outcomes of 24 patients in the EUS-CPN group and 22 patients in the control group were analyzed. EUS-CPN was successfully performed and did not induce severe procedure-related adverse events for all patients in the EUS-CPN group. Although the average pain VAS scores for both groups significantly decreased in comparison with baseline, scores were not statistically different between the groups at week 4 (1.3 ± 1.3 for the EUS-CPN group vs 2.3 ± 2.3 for the control group, P = .10). There was no statistical difference or tendency in favor of EUS-CPN at evaluation points of weeks 1, 2, 8, and 12. Moreover, the average VAS scores for QOL and the average opioid consumption between the groups were not different at all evaluation points. CONCLUSIONS: EUS-CPN for patients with pancreatic cancer-associated pain did not appear to improve pain, QOL, or opioid consumption compared with those who did not undergo EUS-CPN and medicated with oxycodone/fentanyl. Although EUS-CPN can be an option, it was not found to have a large enough impact to be routinely performed for all patients with pain. (Clinical trial registration number: UMIN 000037172.).

[Detection of small pancreatic cancer during surveillance of the main pancreatic duct stenosis].

An 83-year-old man with main pancreatic duct (MPD) stenosis in the pancreatic body had undergone surveillance with semiannual imaging studies for 3 years. During surveillance, magnetic resonance cholangiopancreatography revealed gradual enlargement of a small cyst near the MPD stenosis and contrast-enhanced computed tomography revealed locally progressive atrophic parenchyma in the pancreatic body. On endoscopic retrograde pancreatography, the MPD stenosis was more severe than it had been at diagnosis 3 years earlier. Endoscopic ultrasonography (EUS) showed a 10-mm hypoechoic mass adjacent to the MPD stenosis. The mass was pathologically diagnosed as an adenocarcinoma using EUS-guided fine needle aspiration, and distal pancreatectomy was performed. On histopathological examination, the resected specimen was found to be a moderately differentiated 9-mm invasive ductal carcinoma. Additionally, multiple high-grade pancreatic intraepithelial neoplasms (i.e., carcinoma in situ) were detected in the MPD and branch ducts near the invasive carcinoma.

Endoscopic-ultrasonography-guided biliary drainage for repetitive acute cholangitis of the accessory hepatic duct obstructed by clipping during laparoscopic cholecystectomy.

An 88-year-old man who had been suffering from repetitive fever and abdominal pain every few months for several years was diagnosed with localized acute cholangitis and referred to our center. Various examinations, including computed tomography (CT) and endoscopic ultrasonography (EUS), revealed that the accessary hepatic duct was obstructed by clips used during laparoscopic cholecystectomy performed 7 years previously. It was not possible to approach the completely isolated duct via the transpapillary route. After obtaining fully informed consent, EUS-guided drainage of the occluded duct through the duodenal wall was performed with a self-expanding metal stent. No adverse events related to the procedure were observed, and his symptoms disappeared by the next day. EUS-guided drainage represents a therapeutic option in patients with an accessory hepatic duct, which is iatrogenically isolated by surgical clips.

Pancreatic stent migration into the main pancreatic duct during endoscopic papillary balloon dilation.

We report the first case of pancreatic stent (PS) migration placed early into the main pancreatic duct (MPD) during endoscopic retrograde cholangiopancreatography (ERCP) due to subsequent endoscopic papillary balloon dilation. A 74-year-old woman who complained of fever and abdominal pain was diagnosed with acute calculous cholangitis. On ERCP, a needle-knife precut papillotomy was performed from the orifice because of difficult cannulation. Because of unintentional guidewire insertion into the MPD from the orifice, a PS with bilateral flaps was promptly placed to prevent post-ERCP pancreatitis. After successful biliary cannulation from the orifice alongside the PS, endoscopic papillary balloon dialtion was performed, leading to PS migration into the MPD during the dilation. Two days after the first ERCP, the migrated PS was successfully removed on the second ERCP. The strategy of early PS placement in the ERCP session appears theoretically promising for preventing post-ERCP pancreatitis. However, early PS placement during the ERCP session should be noted to pose the risk of migration into the MPD, especially when pushing the device into the bile duct.

Migration of a Common Bile Duct Stone into the Main Pancreatic Duct due to Catheter Manipulation during Endoscopic Retrograde Cholangiopancreatography.

Introduction: We report the first case of a choledocholithiasis migrating into the main pancreatic duct (MPD) due to catheter manipulation during endoscopic retrograde cholangiopancreatography (ERCP). Case Presentation: A 57-year-old woman complaining of vomiting was diagnosed with acute cholangitis and pancreatitis due to choledocholithiasis. During ERCP, the stone migrated from the papilla into the MPD due to the pushing motion of the catheter. However, the ERCP session was completed after biliary sphincterotomy without intervention in the MPD because the migration was not noticed. The migrated stone became apparent on computed tomography the following day. The second ERCP revealed the stone measuring 5 mm in the MPD. After pancreatic sphincterotomy, a pancreatic stent was placed, which improved the obstructive pancreatitis. Conclusion: Endoscopists performing ERCP should be aware of this rare but serious complication.

The safety and efficacy of Ringer's solution loading with rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: The RESOLUTION-PEP study.

Objectives: We evaluated the safety and efficacy of aggressive hydration with rectal non-steroidal anti-inflammatory drugs for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Methods: This prospective, single-arm, multicenter trial was conducted at 12 institutions between October 2020 and August 2021. We enrolled 231 patients who had intact papillae and were scheduled to undergo ERCP. All patients were administered rectal diclofenac before ERCP. They received aggressive hydration with intravenous lactated Ringer's solution in an initial bolus of 5 ml/kg at the start of ERCP, followed by 3 ml/kg/h for 8 h after the procedure. The primary outcome was the occurrence of PEP. Secondary outcomes included PEP severity, hyperamylasemia, and adverse events. Results: The mean age of the patients was 68.8 ± 13.7 years, and 81 patients (35.1%) were 75 years or older. Thirteen patients developed PEP (5.6%, 95% confidence interval 3.0%-9.4%). There were 11 cases (4.8%) of mild pancreatitis and two cases (0.9%) of severe pancreatitis. Forty-five patients (19.5%) developed hyperamylasemia and one patient developed non-severe peripheral edema. Conclusions: Aggressive hydration combined with rectal diclofenac may be a promising strategy for the prevention of PEP. Furthermore, it is safe even for older individuals.

Endoscopic Laryngopharyngeal Surgery Combined with Endoscopic Submucosal Dissection as a Treatment Option for Superficial Hypopharyngeal Cancer with Suspected Synchronous Lymph Node Metastasis.

We report 4 cases of hypopharyngeal cancer preoperatively suspected with synchronous lymph node metastases. Pathologic lymph node metastasis was confirmed in three of the four cases. All 4 cases underwent endoscopic laryngopharyngeal surgery (ELPS) combined with endoscopic submucosal dissection (ESD) and subsequent lymph node dissection as an optional treatment rather than the standard treatment. Peroral resection for primary site was selected because of the expected decline in quality of life (QoL) after radical surgery. Among 4 patients, one developed local recurrence; however, the other three remained recurrence-free and survived without any additional treatment. Furthermore, the patient who developed local recurrence had a recurrence-free survival for more than 5 years, with additional chemoradiation therapy. No disorders in speech, swallowing, or breathing was observed during the follow-up period. ELPS combined with ESD is generally indicated for laryngopharyngeal cancer without synchronous lymph node metastasis. However, this can be a treatment option for patients may wish to preserve a greater QoL after treatment. In the future, when more data on the results and long-term prognosis of this treatment are accumulated, it may be possible to discuss its validity further.

Mixed neuroendocrine-non-neuroendocrine neoplasm with mucinous adenocarcinoma and amphicrine carcinoma components in the bile duct: an autopsy case.

We report the first case of bile duct mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN) that had a mucinous carcinoma component. An 88-year-old man with biliary obstruction was diagnosed as having distal bile duct cancer using imaging examinations and endoscopic biopsy. The patient received the best supportive care without surgical resection for 13 months until death. An autopsy revealed a bulky mass involving the distal bile duct and multiple metastases in intra-abdominal lymph nodes, the liver, and the lungs. The primary cancer was microscopically diagnosed as a MiNEN, which consisted of mucinous adenocarcinoma and large cell-type neuroendocrine carcinoma (NEC) components. Metastatic lesions in the liver and lungs were composed of only NEC with rich extracellular mucin without adenocarcinoma cells. Using electron microscopy and immunohistochemistry, it was proved that all NEC cells in both primary and metastatic lesions had amphicrine features. On the basis of pathological findings, we thought that the MiNEN was initially derived from a mucinous adenocarcinoma that dedifferentiated to amphicrine NEC cells with mucin production.

Laparotomy-Assisted Direct Cholangioscopy for Bile Duct Stone Removal via an Incision of the Jejunum.

A 77-year-old man presented to our hospital with epigastric pain. He had previously undergone hepatic left lateral segmentectomy, cholangiojejunostomy, and Roux-en-Y reconstruction at 42 years of age for intrahepatic stones and liver abscesses. Abdominal computed tomography and magnetic resonance cholangiopancreatography revealed bile duct stones and intrahepatic bile duct dilation of the caudate lobe. Bile duct drainage for the caudate lobe was necessary; however, the volume of his caudate lobe was very small, making percutaneous transhepatic biliary drainage (PTBD) or endoscopic ultrasound-guided biliary drainage (EUS-BD) difficult. Therefore, we attempted laparotomy-assisted endoscopic biliary drainage. Under general anesthesia, an incision was made on the jejunum approximately 15 cm from the Y-leg anastomosis. An esophagogastroduodenoscope was directly inserted into the common hepatic duct anastomosed with the jejunum. The caudate lobe branch had severe stenosis, and the area upstream of the stenosis was filled with stones, sludge, and pus. The biliary stenosis was dilated using a balloon, and the stones were completely removed using a basket and a balloon catheter. There are various methods of biliary and pancreatic surgery and gastrointestinal reconstruction, and there are cases in which PTBD, EUS-BD, and endoscopic retrograde cholangiopancreatography (ERCP) with an enteroscope are difficult. In such cases, ERCP under laparotomy could be a good treatment option.