T-CAP Tokyo Conference of Asian Pancreato-biliary Interventional Endoscopist

Meeting Summary of T-CAP 2014

Summary of Session 1

Speakers and lecture title

1. Jong Ho Moon: Endoscopic Management of Malignant Hilar Biliary Stricture Dr. Jong Ho Moon presented a keynote lecture about the endoscopic management of malignant hilar biliary stricture (MBS). Endoscopy had an important role for both diagnosis and palliative drainage. He highlighted the importance of histological diagnosis before treatment. Standard brush cytology may be complemented by cholangiosope targeted biopsies and in the event that ERCP based techniques are negative EUS-FNA can be used. In terms of palliative drainage self- expandable metal stents (SEMS) are preferred over plastic stents because of the longer patency. Bilateral drainage can provide longer cumulative patency, and may drain over 50% of the liver volume for adequate biliary drainage. Effective bilateral metallic stenting for hilar MBS may be performed using either a ”stent-in stent” method, or a “side by side” method. In addition to metallic stenting, endoscopic using photodynamic therapy or radiofrequency may possibly prolong the duration of stent patency.

2. Hirofumi Kogure: Stent-in-stent technique Dr. Hirofumi Kogure presented about the stent-in- stent technique. New metallic stents, such as Niti-S Y type or large cell D-type stent, and BONASTENT have been developed for bilateral stent-in-stent procedures. These new designed stents exhibited high technical success rates, low complications, and favorable stent patency.

3. Rungsun Rerknimitr: Malignant Hilar Stricture with side-by-side metallic stenting Discussion “SIS versus SBS”
Dr. Rungsun Rerknimitr presented details about the side-by-side technique. However, there are only a few retrospective studies that compared the differences in outcomes of these two techniques, and the superiority of one technique over the other has not been clearly established. It is clear that in specific situations, the drainage technique must be individualized based on the patient’s biliary anatomy.

4. Do Hyun Park: EUS-guided biliary drainage for hilar obstruction
Dr. Do Hyun Park presented about EUS-guided biliary drainage (EUS-BD) for hilar obstruction. He demonstrated new biliary access with combined modalities on EUS-BD of left intrahepatic bile duct (LIBD) as follows: 1) combined modalities on EUS-BD of LIBD and transpapillary metal stenting of right intrahepatic bile duct (RIBD) in patients with Bismuth IV hilar cholangiocarcinoma; 2) new devices for EUS-BD; 3) photodynamic therapy with S-1; 4)US-guided photodynamic therapy with new photosensitizer.

Summary of Session 2

Speakers and lecture title

1. Shannon Melissa Chan :A pilot study of contrast enhanced harmonic endosonography (CH_EUS) using SONOVUE in the evaluation of suspected pancreaticobiliary and peri-ampullary malignancies

The author underwent CH_EUS with SONOVUE in suspected panceratobiliary and periampullary malignancies for 40 cases and evaluated the sensitivity and specificity compared with golden standard diagnosis (cytology, histology or clinical course). Hypoenhancement on CH_EHS can detect malignancy with a sensitivity of 94.4% and a specificity of 81.0%. There was a comment that CH_EUS may be complementarily useful for the malignant cases which pathological diagnosis suspected false-negative. However, the data of neuroendocrine tumor or IgG4 related cholangitis were not included in this study.

2. Damien Tan Meng Yew: Novel Metabolomics Markers for Characterization and Early Detection of Malignancy in Pancreatic Cysts

Metabolomics was performed on 16 cyst fluid samples obtained via EUS FNA or surgery (4 malignant, 4 premalignant and 8 benign) using LC-MS with identification of key differential metabolites using statistical tools. There was a significant distinction between benign vs. premalignant (B/M) vs. malignant (M) cysts on global profiling. The author recommended the FNA fluid be obtained by single puncture to avoid blood contamination, because blood contains a number of metabolite, and also commented that proteomics or metabolomics are more promising in future than DNA analysis, because DNA is not obtained enough from cyst fluid.

3. Yun Nah Lee: Procore biopsy needle versus standard aspiration needle for EUS-guided sampling of solid pancreatic masses: a randomized study

Consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a Procore biopsy needle (58 patients) or EUS-FNA using a standard aspiration needle(58 patients). 22G needle was used for transgastric approach, and 25G needle was used for transduodenal approach. The overall diagnostic accuracy of combination of on-site cytology, cytology with Papanicolaou stain and histology was not significantly different between the groups (98.3% vs. 94.8%). Compared to the FNA, the FNB required a significantly lower median number of needle passes for diagnosis (1.0 vs. 2.0, p<0.001).

4. Masahiro Itonaga :Endoscopic pancreatic duct stenting for benign pancreatic duct obstruction in our hospital

The authors evaluated the technical results of 7 cases with endoscopic ultrasonography-guided rendezvous drainage (EUS-RD) after failed pancreatic-duct stenting. The all cases were alcoholic pancreatitis, and failed to place a pancreatic stent because of tight stricture (n=2) or obstruction (n=5). EUS-guided pancreatography was achieved in all cases, but EUS-RD was successful in 4 of 7 procedures (57.1%). The failed cases were treated conservatively. There was a comment that pancreatitcogastrostomy were one of the choices after failed ERCP or EUS-RD. However the management strategy of pancreatitcogastrostomy was not standardized yet. Then, surgical treatment may still be one of the options.

5. Akane Yamabe: EUS-guided vascular therapy; Coil deployment for gastric varices. -The first case in Japan-

The authors reported a case of isolated gastric varices(GV) treated by the new technique combined coiling and sclerosant (ethanolamine oleate) injection using interventional EUS. The case was 64 y.o. with liver cirrhosis and isolated GV. GV was using 19G needle. A 0.035 inch coil (10mm in diameter) was inserted into the needle and push the coil using 0.035-inch guide wire. Subsequently second puncture was performed to inject ethanolamine oleate 2 coils. EUS-guided vascular therapy using coil is expected as new treatment for GV instead of cyanoacrylate injection therapy.
The authors commented the number of needed coils used was determined depend on the fluoroscopic image.
There was a discussion on indication, that BRTO is suitable for the cases with gastro-renal shunt. But this case is meaningful in terms of expanding the role of the endoscopic treatment.

6. Osamu Togawa: A Prospective Feasibility Study of Preoperative Biliary Drainage Using a Fully-covered Self-expandable Metallic Stent for Pancreatic Head Cancer

The authors presented multicenter, prospective study to evaluate the feasibility of preoperative biliary drainage using a fully-covered SEMS (FCSEMS). Patients with malignant biliary obstruction due to resectable pancreatic head cancer were treated with a fully-covered biliary Wallflex(TM). Primary endpoint was pre- and post-operative complications. Seven patients did not undergo surgical resection. The remaining 17 patients underwent surgical resection after a mean of 18 days from stent placement. Neither stent occlusion nor pancreatitis was observed prior to surgery. Preoperative complication rate was 12% (Cholecystitis, insufficient biliary drainage). Postoperative complications occurred in 8 patients (47%). The use of FCSEMSs can potentially reduce preoperative stent-related complications compared with plastic stents.
There was question about waiting time. Pancreatoduodenectomy was normally performed after the normalization of bilirubin level in Japan. There were comments on primary endopoint and stent selection(covered or uncovered).

7. Sang Hyub Lee: Small cell versus large cell-sized stent for endoscopic bilateral stent-in-stent placement of metallic stents in malignant hilar biliary obstruction

The aim of this study was to compare the clinical outcomes of endoscopic bilateral SIS placement according to the cell size of self-expandable metallic stent (SEMS). 43 patients with biliary tract cancers who underwent successful stent insertion were divided into the small cell-sized stent (SCS; BONASTENT M-Hilar) and large cell-sized stent (LCS; Niti-S large cell D-type biliary stent) groups, and retrospectively compared. Both groups did not differ significantly in procedure-related complications (38.1% vs. 18.2%), 30-day stent occlusion (0% vs. 9.1%), 30-day mortality (4.8% vs. 9.1%), late complications (14.3 vs. 22.7), and endoscopic reintervention (66.7% vs. 50%). Kaplan-Meier analysis showed that the stent patency duration and survival period were not significantly different between the two groups.
There was a comment that cell size is not related to tumor ingrowth. In this study tumor ingrowth was not also related stent patency because of tumor behavior.

8. Tomoharu Yamada :Endoscopic management of bile leaks after hepato-biliary surgery or percutaneous biliary procedures.

The authors reported the effectiveness of EST, biliary stenting, nasobiliary drainage, and endoscopic N-Butyl 2-cyanoacrylate injection in the management of bile leaks. The 24 cases with biliary leakage (open cholecystectomy 11, laparoscopic cholecystectomy 1, hepatectomy 3, PTBD 9) were retrospectively analyzed. Of 24 patients, 9 cases were treated with N-Butyl 2-cyanoacrylate injection to fistulas. All but one patient successfully treated without any major complications or bile leak recurrence. Endoscopic therapy is safe and effective in the management of bile leaks.
Especially, N-Butyl 2-cyanoacrylate is effective for biliary leakage from immature PTBD fistula. There was discussion on the use of covered metal stent. The author commented that metal stent may be effective for the cases which metal stent can cover or bridge over the fistula (cystic duct leakage), but in the cases with PTBD fistula, N-Butyl 2-cyanoacrylate is effective.

Summary of FUJIFILM Corporation Luncheon Seminar

Speakers and lecture title

1. Peter Draganov: Pancreatic Cystic Lesions


2. Yousuke Nakai: Recent Progress in Interventional EUS

Summary writer: Shomei Ryozawa (Saitama Medical University International Medical Center)

Dr. Yousuke Nakai delivered a lecture entitled “Recent progress in Interventional EUS”. During his lecture, he highlighted the potential application of Interventional EUS especially in the pancreaticobiliary field and shared his experience with audience.

Since its introduction, EUS has its main role as a diagnostic tool: imaging and tissue acquisition. However, EUS was destined to expand its indications into treatment. Using EUS, we can access wherever we want as long as accessible under EUS guidance.

Interventional EUS has been developed first as an alternative to ERCP: EUS-guided rendezvous or biliary drainage, pseudocyst drainage. EUS is now utilized for gallbladder drainage or endoscopic necrosectomy. The unmet needs in this area are the development of dedicated devices for interventional EUS.

The other area of interest is EUS-FNA needle as an access for diagnostic tools: Throuht-the-needle imaging or biopsy. Recent development of miniature probe-type imaging tool like a confocal laser endomicroscopy enables through-the-needle imaging. These novel imaging techniques are utilized in the diagnosis of pancreatic cystic neoplasms as reported in their DETECT study. They also reported EUS-guided through-the-needle biopsy using a 0.75-mm miniature biopsy forceps, giving additional specimen to regular EUS-FNA with a single pass of 19G needle. This through-the-needle technique will be also utilized for tumor ablation.

Summary of Session 3 Special Lecture

Speakers and lecture title

1. Nonthalee Pausawasdi: Endoscopic management of ampullary lesion

2. Arthur Kaffe: Metal stents in benign biliary strictures

Coming Soon

Summary of TaeWoong & CMI Satellite symposium

Speakers and lecture title

1. Myung-Hwan Kim: Endoscopic Treatment for Main Pancreatic Duct Injury Associated with Acute Necrotizing Pancreatitis
Summary writer:　Hiroyuki Isayama (Tokyo Univ. Japan)

Sever acute pancreatitis (SAP) sometimes causes pancreatic duct (PD) disruction. In this situation, the length of hospital stay become longer and the patients required additional interventional or surgical procedure. From Asan Medical Center experiences, the incidence of PD disruption is associated with the over 50% of necrosis in the pancreatic parenchyma. There are 2 types of PD disruption; partial and complete. Complete disruption may be developed disconnected pancreatic duct syndrome (DPDS). We can suspect the DPDS from following clinical signs; 1) Amylase rich pleural effusion or ascites, 2) Un-resolving fluid collection, 3) Atypical fluid collection (mediastinal or pleural), 4) Persistent high amylase level drainage from the percutaneous catheter. Endoscopic stenting across the disruption area is effective, but for the DPDS case, it is almost impossible. EUS-guided transmural drainage with fully covered self-expandable metallic stent (FCSEMS) is also effective drainage method. The length of stent placement is within 2month for PS and 6month for FCSEMS. In DPDS case, we cannot stent across the disruption and tranmural approach is recommended. Percutaneous approach may cause permanent pancreatic-cutaneous fistula and we should avoid this approach first. From the discussion, Prof. Kim remove the FCSEMS 6months after placement, and replace the multiple plastic stent. 1year after initial treatment, he removes the plastic stent, and observe. If the fluid collection is recurred, he refer the patient to the surgical department.

2. Manuel Perez Miranda: Place of Hepaticogastrostomy Guided by EUS for Biliary Drainage
Summary writer:　Thawee Ratanachu-ek(Chief of general surgery division, departmentt of surgery, Rajavithi hospital)

I shall talk 8 topics as follow 1. History, 2. Concept, 3.EUS-HG versus other EUS-BD options, 4. Learning curve, 5.Complications, 6. Techniques, 7.HG for drainage and 8. HG for Drainage and Intervention.
History: Hepaticogastrostomy (HG) is almost 20 year old. Percutaneous Hepaticogastrostomy was first intervened under laparoscopic and endoscopic guidance by intervention radiologist in 19941. Sahai AV et al. 2 created EUS guided hepaticogastrostomy technique in 5 pigs successfully. The first human cases of EUS guided biliary drainage so called choledochoduodenostomy (CD) performed by Giovannini M et al. 3, since then the EUS assisted technique for pancreatobiliary drainage via transpapillary antegrade, transpapillary Rendezvous (RV) and transmural worldwide spreading especially from 2005-2014. The first truely prospective trial study by Park et al. 4 of EUS guided biliary drainage with one-step placement of a fully covered metal stent for malignant biliary obstruction, the success rate was 100% and more importantly the long-term dysfunction rate was very low (7%).
Concept: I donot think the terms EUS guided hepaticogastrostomy has been used properly because not only endoscopic ultrasound but also fluoroscopic assisted as well so the term EUS guided is very broad name. What’s ever the name, EUS guided biliary drainage considers to be the access ( intrahepatic versus extrahepatic) and drainage route (transmural versus transpapillary). Transpapillary drainage can be done by antegrade or Rendezvous technique. EUS biliary drainage (ESC, EAC, EGC, EGBD) as a parent procedure with six variant approach. Hepaticogastrostomy is one of this family.

EUS-HG versus other EUS-BD options: EUS-HG relates to the other procedure. Generally, the people think 1, Rendezvous (RV) is better than transmural. 2, Antegrade (AG) is better than transmural. 3, Choledochoduodenostomy (CD) is better than hepaticogastrostomy (HG) based on the evidence but I donot think so. Start with RV first, EUS guided Rendezvous technique is higher success rate than precut technique (98.3% vs 90.3%,p .03) and complication rate is very low (3.4% vs 6.9%,p.27) in retrospective study from Mumbai5, India. It’s better than our center that success rate only 70%. The reason of high success rate in Mumbai group is this center creates a very good 3-D model for learning EUS guided biliary drainage technique especially wire manipulation by assistant. They use short terumo 260 cm long wire and exchange with water injection to push the wire out. The extrahepatic RV technique, the needle direction is downward to ampulla but sometime the direction is upward so flexible devices is important for manipulating wire down. However, the decision to do any technique, RV vs direct access or intrahepatic vs extrahepatic route, depends on the patient anatomy and location of lesion. The study from Mumbai6 also shown intrahepatic Rendezvous technique is more complication, such as post-procedure pain (44.1 vs. 5.5%; p 0.017), bile leak (11.7 vs. 0; p 0.228), and air under diaphragm (11.7 vs. 0; p 0.228) than extrahepatic approach in distal CBD obstruction with the same success rate (94.1 vs. 100%) and also shown by Asan Medical Center (AMC, Korea) study7 that either antegrade or RV via intrahepatic route, the success rate drop to 50% from the success rate 90% whenever use RV or direct access via extrahepatic route, so RV per se is not the answer, intra- or extrahepatic route has the impact.

Learning curve: We learned from our center, from the beginning (2004) the success rate and complication is almost the same (56% vs 38%) in our first 40 patients then 3 year later (2006), our success rate is 79% and complication was drop to 18%. Multicenter spanish ESCP (Endo-Sono Cholangiopancreatography) shown the success rate in first 20 cases is very low. So we also developed the animal model for training course.
We use ovesco clip to make bile duct dilatation for practicing, however the Mumbai 3-D model must more interesting in term of repeat practicing and lower cost comparing with pig model.

Complication: The complications come from the learning curve and the mistake. Our Spanish study shown complication 23% and mortality 4%.
We try not to use cautery but if need, do not use needle knife, it makes more complication as study from AMC8. We use cystotome. The other example is the stent migration might be from miss calculation the length because the shortening of wallstent make it migrate. So to prevent this complication we keep the stent in stomach longer and sometime put the double pigtail stent inside the metal stent to fix it and also to prevent impact the opposite gastric wall. Judge be fair, the complication, right now might be same as the complication from the early period of ERCP technique so a lot of new devices are coming up probably decrease this problem.

Technique: For HG, we choose dilated duct of B2 or B3, typical in B2, and its direction into hilum, not to periphery, try to keep puncturing site close to dilated duct as much as possible about less than 2 cm. we always use 19G needle then put the suction syringe on to get the bile. However, we use 22G needle in case of small duct in this situation I inject the saline into the duct to expand the duct and then change to repuncture with 19G needle. The use of 0.018” wire is useless. We make graded dilation with balloon catheter same as pseudocyst drainage reported by Varadarajulu S9. and also aspirate the bile to make sure that it’s into the duct not in the peritoneum. The last tips on technique is metal stent. The metal stent is beneficial in term of track sealing and long-term patency so we try to always use fully covered stent 6 or 8 cm. and sometime dilate metal stent then insert double pigtail plastic stent to prevent complication for example to reposition in case of stent inward migration and also anchoring stent with hemoclip if technical is possible. In case of plastic stent insertion, we use over the wire exchange technique, however sometime we cannot get the wire into the stent so we put the wire parallel with stent, not loose the access in the difficult situation to remove the stent, we cut the pigtail loop with polypectomy snare to facilitate removal then remove it parallel with wire into the channel and then we place plastic with covered metal stent.

HG for drainage: Multicenter retrospective study of EUS-BD by Kuwakubo K et al.10 shown high success rate 95%, but only 1/3 for HG. In our data, only 20% was extrahepatic. One small study11 shown long-term patency transmurally is better than transpapillary. The application for HG is to drainage bile in case of obstructed duodenum that CD is not possible and, secondly to drainage on the left side in case of previous metal stent placement in the right and, thirdly to make internalize tract to correct long standing percutaneous biliary drainage from the advanced gallbladder cancer and also can do antegrade metal placement via HG.

HG for Drainage and Intervention: We can create temporary HG in patient with altered anatomy to access bile duct same as PEG (percutaneous endoscopic gastrostomy) to access inside the stomach by keeping FCMS placement for 3-4 week and remove it then we can use this fistula for the other bile duct intervention such as stone removal, assisting ERCP scope insertion. In case of bile transaction, we use combined percutaneous-ERCP to reconnect and also we can use transgastric approach

HG likes PEG (percutaneous endoscopic gastrostomy) to access inside the stomach. For example, we can create the new bile duct access via stomach (so called temporary HG) after keeping FCMS placement for 3-4 week and remove it then we can use this fistula for the other bile duct intervention such as stone removal

Inconclusion: HG comes a long way in 20 year. It’s one of the most useful procedure for biliary drainage and also allow internal fistulization for the other biliary intervention. It’s a long learning, complication will be blocked down due to careful attention in detail techniques and devices improvement and it also requires expertise in EUS and ERCP as well.

Reference:

1.Soulez G, Gagner M, Thérasse E, Deslandres E, Pomp A, Leduc R, et al. Malignant biliary obstruction: preliminary results of palliative treatment with hepaticogastrostomy under fluoroscopic, endoscopic, and laparoscopic guidance. Radiology. 1994;192:241-6

2.Sahai AV, B.J. Hoffman, R.H. Hawes. Endoscopic ultrasound-guided hepaticogastrostomy to palliate obstructive jaundice: preliminary results in pigs (abstract). Gastrointest Endosc.1998;47:AB-37

3. Giovannini M, Moutardier V, Pesenti C, et al . Endoscopic ultrasound-guided bilioduodenal anastomosis: a new technique for biliary drainage. Endoscopy 2001; 33:898-900.

4. D. H. Park, J. E. Koo, J. Oh et al., “EUS-guided biliary drainage with one-step placement of a fully covered metal stent for malignant biliary obstruction: a prospective feasibility study,” Am J Gastroenterol 2009;104:2168–2174, 2009

5. Dhir V1, Bhandari S, Bapat M, Maydeo A. Comparison of EUS-guided rendezvous and precut papillotomy techniques for biliary access (with videos). Gastrointest Endosc. 2012;75:354-9.

6. Dhir V, Bhandari S, Bapat M, Joshi N, Vivekanandarajah S, Maydeo A. CBD obstruction Comparison of transhepatic and extrahepatic routes for EUS-guided rendezvous procedure for distal CBD obstruction. United European Gastroenterology Journal 2013;1:1-6

7. Park DH, Jeong SU, Lee BK, et al. Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video). Gastrointest Endosc 2013;78:91-101

8. Park DH, Jang JW, Lee SS, et al. EUS-guided biliary drainage with transmural stenting after failed ERCP: predictors of adverse events and long-term results. Gastrointest Endosc 2011;74: 1276-84

9. Varadarajula S. Endoscopic management of pancreatic pseudicyst. Journal of Digestive Endoscopy 2012;3:58-64

10. Kawakubo K, Isayama H, Itoi,T, et al. Multicenter retrospective study of endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction in Japan. J Hepatobiliary Pancreat Sci 2014;21:328-34

11. Hamada T, Isayama H, Nakai Y, et al. Transmural biliary drainage can be an alternative to trnaspapillary drainage in patients with an indwelling duodenal stent. Dig Dis Sci 2014;59:1931-8

Question:

Dr. Ryan: Lovely presentation, you dilate metal stent before placing double pigtail stent. Does double pigtail stent prevent stent shortening anyway?
Dr.Miranda: No,it does not prevent. In case of dilation, the stent over the time slip out of the duct, you have stent inside. I recommend soft small pigtail 7 Fr.
Dr. Ryan: you use 6 Fr.cystotome, you try without cautery first if does not work, using cautery
Dr.Miranda: Yes.
DR.Ryan: Do you use outer sheath of 19G needle to dilate?
Dr.Miranda: No.
Dr.Ryan: Last question, when you cautery through the stomach, you still use caurtery in liver parenchyma or you use force.
Dr.Miranda: after cautery through the stomach, we put the cystotome with good traction with wire and use cautery.
Dr.Kitano: we keep stent longer in luminal site, may be 3-4 cm long, to prevent migration
Dr.Miranda: We use covered stent so in intrahepatic site, we do not keep too long to avoid to occlude the duct but for small duct is not the problem.
I use 6-8 cm long, maximum. I agree with that the longer is easiler.
Dr.Ryan: Giobor is partially covered and partially uncovered inside to prevent obstruction of biliary system. I think the long stent is safer.
Dr. Miranda: Yes, may impair long-term dysfunction. The long-term patency is good but less problem than migration. Definitely, more deviced is coming up make this procedure is more suitable.
Dr.Maydeo: How many day you keep the good tract for intervention via HG.
Dr.Miranda:2 week then take the stent out and insert the cholangioscope or ultrathin gastroscope.
Dr.Hara: Nice presentation, I recommend CD.
Dr.Miranda: I like too. I start with ERCP first if blockage then move to CD or HG.
Dr.Hara:Can HG become the first line therapeutic.
Dr.Miranda: No, ERCP is the first line therapeutic for CBD stone removal since 1974. Right now for HG is not but I do not think CD either is the first line procedure.
Dr.Ryan: How about the consent, you brink the patient back when you fail ERCP?
Dr.Miranda: Basically, we get the consent for everyting even anesthesia, we can do everything if it’s fit for the patient apropiately.

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