Our next clinical spotlight features a portal vein thrombosis (PVT) case treated by Dr Malkhaz Mizandari and his team at the Tbilisi State Medical University (Georgia).  Dr. Mizandari went on to publish a wider case series using similar techniques as those described in the individual case review below. That paper was published in the Universal Journal of Medical Science and can be found here.

A 60-year-old man was admitted with a history of three weeks of fatigue and abdominal discomfort. He was diagnosed with hepatitis C induced liver cirrhosis (Child-Pugh B). The CT scan reported a vascular mass in the left lobe with total thrombosis of the left portal vein.  The thrombus had advanced into the main PV, so that only the right branch remained patent. Blood tests showed severe hypoalbuminemia (25 g/L) and thrombocytopenia (70), moderate hypocoagulation (INR - 1,48, PT - 16,8, PT% - 61,9) and moderate changes of liver enzymes (AST - 99,8 u/L, ALT - 76,0 u/L, GGT - 158 u/L). He underwent percutaneous ultrasound (US) guided biopsy of the left lobe mass, confirming the presence of HCC. 

Because of the PV thrombosis, the patient was not a candidate for surgical resection or a TACE procedure. The HabibTM VesOpen procedure which aimed to restore normal blood flow to the right PV was approved following a multi-disciplinary team (MDT) discussion.  The right PV was accessed through an 18 G puncture needle using real-time US guidance. Portography with contrast dye showed the position of the upper border of the PV thrombus.  A 0.035” wire was passed through the thrombus into the superior mesenteric vein (SMV) using a 5Fr guide catheter and portography "below" the thrombus was performed to identify the "lower" border of the PV thrombus.

An 8 Fr introducer sheath was positioned and the 5Fr endoluminal device (HabibTM VesOpen – not available for sale in the United States) was introduced into the thrombus for 2 consecutive sessions of radiofrequency ablation using a RITA 1500X generator set at 15W for 120 seconds  (to ensure that the entire length of the stricture was ablated) . A 14 mm diameter self-expanding vascular stent was positioned into the thrombus and post-dilated with a 10mm balloon (Cook Medical, Winston-Salem, North Carolina, USA). Postprocedure portography showed complete restoration of the patency of the main PV, restoring normal blood flow into the right portal vein.  During withdrawal of the VesOpen, catheter, the transhepatic access route was also ablated to prevent restored blood flow from the PV entering the peritoneal cavity.

The patient's condition improved gradually; eight weeks after the procedure his albumin increased to 32 g/dL. Improvement of coagulation (PT, PT%, APTT, INR), liver function tests, appetite and other functional indicators improved as well. The patient refused to undergo TACE but a repeat CT scan 5 months after the Habib VesOpen procedure revealed a significant decrease in the size of the tumour, and both PV branches were patent (including the untreated left branch).

The clinical team concluded that the decrease in tumor mass and the restoration of blood flow in the left PV could likely be explained by an immune response induced by the RF treatment.

As seen in the below image from WCIO 2016, Dr. Mizandari also performs RFA in the bile and pancreatic ducts. More on those treatment methodologies later!

Posted
AuthorFrancois Poulin

 

In the spotlight today is Dr. Stephen P Pereira and team in the UK at UCLH, who have published a very positive case about the treatment of a pancreatic neuroendocrine tumor (pNET) with the Habib™ EUS RFA device.

The 18mm tumor in the head of the pancreas of the 70-year-old female patient, was identified on CT scan and confirmed with EUS visualization and FNA. The patient was a poor candidate for surgery, so when other initial therapies (Diazoxide, low GI diet) were not successful, the team proceeded to RFA.

As you will see, the authors support the use of EUS-RFA treatment in the management of patients with functional pancreatic neuroendocrine tumors who have failed multiple therapies and cannot undergo surgery due to comorbidities.

"After the final EUS-RFA treatment, the patient's glucose requirements ceased and octreotide therapy was withdrawn...the patient remained well and asymptomatic at 10 months follow-up."

In 2009, a similar case was reported (15mm pNET located in tail of pancreas) where the patient was successfully treated with CT-guided percutaneous RFA. While this demonstrates the fundamentals of RFA at work on a similar tumor, the benefit of EUS access today is a smaller and more manoeuvrable device that can reach more challenging anatomical spaces such as the tail of the pancreas. Smaller devices used at lower power settings have been developed in an attempt to reduce complications.

Reported results from 2015 on larger-sized (27.5mm) unresectable pNETs showed that EUS RFA therapy was safe and straightforward, and this case from Dr. Pereira further demonstrates the success potential of the therapy where indicated.

The full publication of the recent pNET case can be accessed here, and below is an exclusive video of Dr. Pereira discussing the case during a meeting at Hammersmith Hospital late last year.

While this case shows one use for EUS RFA, others are in process, including the randomized controlled RADIOCYST trial and several others which will be discussed at the upcoming EUS & HPB RFA Focus Group at DDW (more info and schedule here).

 
Posted
AuthorKim Adams

Our next case study comes from Dr Hemchand Ramberan from the Program in Advanced Therapeutic and Interventional Endoscopy at Erlanger Hospital in Chattanooga TN.  

PATIENT PROFILE:

A 49 year old Caucasian male presented with jaundice, puritus and RUQ discomfort. He was noted with obstructive jaundice on liver profile with Total bilirubin 9.6 MG/DL, Alkaline phosphatase 440 U/L, AST 180 U/L, ALT 165 U/L, Platelets 45,000 TH/MM3, WBC 2400 TH/MM3 and INR 1.5.  A RUQ US and CAT scan demonstrated a markedly distended gallbladder and dilated bile ducts without any obvious stones. ERCP at his local hospital described a distal CBD stricture and brushings for cytology were non-diagnostic. He also had clinical features and a history that were consistent with cirrhosis related to alcohol.

He underwent a follow up EUS/FNA and ERCP with cholangioscopy and biliary plastic stent placement.  EUS revealed focal abnormal irregular hypoechoic thickening of the terminal bile duct. Cytology from EUS FNA and brushings confirmed adenocarcinoma. ERCP demonstrated an irregular 15 mm terminal CBD obstructing stricture with shouldering. He was also noted with mild portal bilopathy extending from the proximal to distal CBD. A follow up CA 19-9 was 172U/mL and a staging MRI reveals no metastatic or locally advanced disease.  Though he had localized malignancy, he was considered not to be a surgical candidate due to his severe portal hypertension with markedly dilated periportal varices. Chemotherapy was also not an option due to his relative significant pancytopenia.

MRCP with terminal CBD malignant stricture and indwelling CBD stent

MRCP with terminal CBD malignant stricture and indwelling CBD stent

ENDOSCOPIC INTERVENTION:
Given that he was not a candidate for standard treatment options by curative surgery or palliative chemotherapy, he was offered the option of intraductal RFA with the Habib Endo HPB catheter.  Three sessions of intraductal RFA were performed at 8 week intervals with standard application with an ERBE ICC 200 electrosurgical generator utilizing 10 Watts for 120 seconds and with plastic stent replacement at the patient request.  There was mild self limited intraductal bleeding noted after the first two sessions of RFA but no other immediate or delayed complications from the procedure.

ERC showing distal CBD stricture

ERC showing distal CBD stricture

EUS FNA of terminal CBD stricture

EUS FNA of terminal CBD stricture

EUS FNA of terminal CBD stricture Diff Quik with cluster of Atypia

EUS FNA of terminal CBD stricture Diff Quik with cluster of Atypia

Cellblock with malignant cell (adenocarcinoma)

Cellblock with malignant cell (adenocarcinoma)

Spyglass Cholangioscopy of terminal CBD revealing abnormal neoplastic raised epithelia

Spyglass Cholangioscopy of terminal CBD revealing abnormal neoplastic raised epithelia

ERC with intraductal RFA of terminal cholangiocarcinoma using the Habib EndoHPB catheter

ERC with intraductal RFA of terminal cholangiocarcinoma using the Habib EndoHPB catheter

Spyglass cholangioscopy after intraductal RFA, note the ablation of the raised neoplatic epithelia

Spyglass cholangioscopy after intraductal RFA, note the ablation of the raised neoplatic epithelia

PATIENT OUTCOME:
Six months and a year later after his last treatment with intraductal RFA, there has been no progression of his malignant stricture and follow up MRI reveals no evidence of locally advanced or metastatic disease. His CA 19-9 has significantly decreased from 172 U/mL to 42 U/mL though he remains pancytopenic and with compensated cirrhosis. He continues to prefer plastic stent service at 3 to 4 months intervals rather than a permanent biliary self expandable metal stent.

DISCUSSION:
Though the standard of care for cholangiocarcinoma is surgical resection with curative intent and possibly adjuvant or palliative chemotherapy, this case is an example of favorable response that appears to be sustained a year after treatment for a pathology that is known to be notorious for rapid spread and metastasis within a short period from the time of diagnosis and sometimes even with palliative chemotherapy.
The objective findings in this case demonstrate neither progression of the known malignant stricture nor any evidence of local spread or distant metastasis after intraductal RFA with the Habib EndoHPB catheter. It raises questions as to whether this is truly an effective modality of treatment in this particular case or it represents a different tumor biology that was responsive to RFA when the patient had no other therapeutic options despite localized disease but was not an acceptable candidate for surgery.

 

Posted
AuthorFrancois Poulin

Our second clinical spotlight features an IPMN case treated by Dr Raj Shah and his team (Drs Nicholas Brown and Joel Camilo) at the University of Colorado.  We recommend that you be on the lookout for a more detailed journal publication over the next few months. (Update: the case is now published formally and can be accessed here.)

A 79-year-old man was admitted with two weeks of fatigue, abdominal discomfort and jaundice. He was an active smoker. Physical exam revealed a frail, debilitated male with jaundice, icterus, and mild tenderness to palpation in the right upper quadrant and epigastrium. CT scan reported a pancreatic head cystic mass with both biliary and pancreatic ductal dilatation. He underwent ERCP and EUS-FNA with plastic stent placement. Cytopathology revealed IPMN without dysplasia. He was referred to the University of Colorado Hospital due to persistent jaundice and failure to thrive despite biliary stenting.  

Contrast-enhanced computed tomography (CT) demonstrated a diffusely dilated main pancreatic duct (16 mm), multiloculated cystic mass (6 cm) in the pancreatic head and uncinate process, evidence of biliary obstruction with intra- and extrahepatic ductal dilation up to 18 mm and moderate narrowing of the portosplenic confluence. Due to poor operative candidacy given functional status and CT findings, palliative options were pursued along with additional tissue sampling to confirm suspected malignancy. Repeat EUS and ERCP at UCH was performed one week after the index procedures at the referring hospital. The ampulla had the typical gaping orifice seen with IPMN but included both the biliary and pancreatic orifice. Cholangiography revealed mucinous filling defects in the lower and mid bile duct with marked dilatation. After forceps biopsy from the pancreatic duct, two overlapping covered self-expanding metal stents with the downstream stent bridging the papilla were placed.  

Cholangiopancreatography revealing mucinous filling defects in both ducts at follow-up ERCP of index biliary RFA session

Cholangiopancreatography revealing mucinous filling defects in both ducts at follow-up ERCP of index biliary RFA session

Histology revealed mucinous epithelium with low-grade dysplasia and EUS-FNA of the pancreatic head cyst revealed IPMN with moderate dysplasia. The patient’s bilirubin improved initially but rose again to 22.6 mg/dL prompting repeat evaluation locally one week later. Repeat CT demonstrated that the previously placed stents had migrated entirely out of the extrahepatic ducts into the rectum which were subsequently passed naturally. He remained too fragile for surgical resection and was sent for consideration of repeat endoscopic therapy. Biliary RFA was pursued after careful discussion with the patient on the potential benefits and risks. He underwent two separate sessions of RFA via ERCP two months apart.   During both procedures the bile duct was explored endoscopically using the Boston Scientific SpyGlass direct visualization system.

Cholangioscopy under fluoroscopic guidance confirmed a villous mass with a fistulous connection between the area of the pancreatic head cyst and the extrahepatic bile duct. Further, given the mucinous filling defects within the bile duct, it was difficult to discern the exact margins of tumor involving the bile duct and thus, cholangioscopy was used to fluoroscopically mark the upper and lower margins of the villous tumor burden.

Fluoroscopic images of the cholangioscope at upper and lower margins of the visualized villous mass

Fluoroscopic images of the cholangioscope at upper and lower margins of the visualized villous mass

During his first RFA, the HabibTM EndoHPB was advanced over a .035” wire and to the upper, mid and lower margins of the tumor as estimated by the fluoroscopic spot films of the cholangioscope position. Three ablations were performed (8W, Effect 8 and 90 seconds each site with one minute “cooling” interval prior to adjustment to an additional site) under fluoroscopy guidance. Three side-by-side plastic stents were placed. Seven weeks later, he had clinically improved with respect to jaundice, appetite, and weight. Cholangiography revealed a subjective improvement in the degree of mucinous filling defects. He underwent a second biliary RFA session that included two overlapping stations (8W, 90 seconds per application) under cholangioscopy and fluoroscopy guidance as described above. Prior stents were partially occluded with mucin and tumor and these were replaced.

Three weeks later, his CA 19-9 had dropped to 142 unit/mL, total bilirubin to 1.3 mg/dL and albumin rose to 3.1 g/dL. Appetite, functional status, and weight improved as well. A repeat CT showed a grossly unchanged cystic mass in the pancreatic head, main PD dilation to 18mm and extrahepatic ductal dilation to 20mm but the surgical team felt that the cystic mass, though it appeared that his entire main duct was involved, had an improved plane with the major vessels for potential resection. Due to this and his improved functional status five weeks after his last RFA session, he underwent a classic Whipple’s surgery with portal vein reconstruction. Intraoperative frozen sections of the bile duct were negative, a margin on the portal vein was negative and the neck margin of the pancreas did not have malignancy, although it did have IPMN. All gross disease at the level of pancreatic head cystic mass was resected. The final surgical pathology showed IPMN with high-grade dysplasia/carcinoma in situ, with the pancreatic neck margin revealing moderate dysplasia.  He is clinically well and at pre-illness functional status 17 months following surgery.  

Posted
AuthorFrancois Poulin

Welcome to the EMcision blog, which is intended to allow the medical community to share their experiences and recommendations when using radiofrequency ablation in the gastrointestinal tract.

This first post presents a case from Dr Sri Komanduri at Northwestern University in Chicago, where RFA was used in a patient with an uncovered metal stent and recurrent episodes of cholangitis.  Tumor ingrowth was confirmed visually and energy was delivered to this tissue prior to re-stenting.  The procedure posed no technical issues and bile flow was restored.  At 2 months follow-up the patient was doing well without any further sign of tumour re-growth.

The floor is yours!

Posted
AuthorFrancois Poulin
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