None listed
Conditions
Brief summary
Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with a “Malignant Hilar Biliary Stricture” (or MHS), and require a stent. Purpose of the Study To assess two types of established stent placement techniques: Stent-By-Stent (SBS) and Stent-In-Stent (SIS). They will be compared in terms of stent patency, technical success, and complication rates, which will be assess at the end of the procedure day, and two follow-up visits. Study Details All participants will undergo an Endoscopic Retrograde Cholandio-Pancreatography (or ERCP). This is performed under sedation, and you are not likely to feel the entire processs. The ERCP procedure uses a thin tube with a camera which passes into your throat so we can have a better view of your gastrointestinal tract. The scope will travel down into the place where the bile duct meets the small intestine. A special dye will be injected into the affected bile ducts and an x-ray will be used to watch the flow of the dye to see where the blockage is. Then the stents will be put inside the relevant bile ducts using small guide-wires. Once the stent is inserted in the right place the wire is removed, and the bile duct will be unblocked and should drain normally. Because of your condition, you will require two stents placed in the ‘left’ and ‘right’ hepatic ducts within the liver. If you agree to participate, you have an equal chance of being randomised to receive one of the two stent placement techniques; SBS or SIS. (1) For the SBS group, two separate guide-wires will be fed into the left and right bile ducts at the same time. The first stent will be deployed into the left duct, and then the second stent will then be deployed into the right duct, and the guide-wires are removed. (2) For the SIS group, the first guide-wire will be fed into the left or right duct, and the stent will then be deployed and the guide-wire will be removed. Then, the second guide-wire will pass through the mesh of the first stent, into the remaining duct, and the second stent will be deployed while sitting through the first stent (creating a “Y” shape). You will be asked to attend a review visit with the investigator at 3 months and 6 months following your procedure. Your ongoing treatment and follow up will then be planned by your treating practitioner. We are particularly interested in investigating the choice of placement with a type of metallic stent, which has shown superior patency to plastic stents in recent studies. However, it is not clear which type of placement is favoured for metal stents for MHSs. We hope this research will help provide further information on the safety and usefulness of stent insertion techniques of MHSs and potentially other gastrointestinal disorders that require stents
Interventions
After obtaining informed consent, the recruited patients will be randomized, in a 1:1 ratio, to either the Stent-In-Stent (SIS) or Stent-By-Stent (SBS) group before insertion of a duodenoscope for the placement of bilateral metal stents, via Endoscopic Retrograde Cholangiopancreatography (ERCP). The randomization is computer generated random numbers for block randomization (block size of 16).
The ERCP procedure will be performed after an overnight fast. The patient’s position and mode of sedat
After obtaining informed consent, the recruited patients will be randomized, in a 1:1 ratio, to either the Stent-In-Stent (SIS) or Stent-By-Stent (SBS) group before insertion of a duodenoscope for the placement of bilateral metal stents, via Endoscopic Retrograde Cholangiopancreatography (ERCP). The randomization is computer generated random numbers for block randomization (block size of 16). The ERCP procedure will be performed after an overnight fast. The patient’s position and mode of sedation will be at the discretion of the endoscopists. Prophylactic antibiotics should be used before, during, and 3 days after the ERCP procedure to minimize risk of cholangitis, which is substantially high in this group of patients. The requirement of a longer course of antibiotic will be guided at the judgement of the caring physician. Analgesics (Fentanyl or Meperidine) will be allowed during and after the procedure. All cases will be performed by the participated investigators, who are highly experienced ERCP-ists at their own tertiary referral centres. Trainees will not be permitted to perform the endoscopic procedures. Careful pre-ERCP assessment of the biliary tract is essential and will be based on CT and/or MRCP images. Atrophied liver and dominant right or left portal vein occlusion sites with or without liver atrophy were avoided as much as possible to effectively drain the liver volume. Based on these findings, decision on which branch should be drained will be determined pre-ERCP. Overall, two of the 3 major hepatic branches, the right anterior, the right posterior, or the left lobe of the dominant biliary branch, will be selected for drainage. Temporary biliary decompression was permitted while waiting for pathologic confirmation and the decision regarding operability. After defining the anatomy of the biliary tract and identifying the dominant branches that need to be drained, guidewires will be placed into the relevant ducts. For SIS deployment: after insertion of the guidewires into both Intrahepatic Ducts (IHD), bilaterally, the first stent, with a radiopaque “X” mark, will be inserted into the left or right IHD. After deploying the first stent, a guidewire will be passed through the stent into the contralateral bile duct. Then, the second stent will be deployed through the wire mesh of the first stent. For SBS deployment: after passing 2 guidewires into both IHDs using the same method as used for SIS deployment, the first stent will be deployed into the left hepatic duct and the second stent into the right hepatic duct sequentially. During deployment of the first stent, the second stent will be preloaded on a guidewire to facilitate immediate placement of the bilateral SBS. For both groups, the expected duration of the ERCP procedure is 30-40 minutes. In both SIS and SBS cases, the distal end of the stents will be positioned across the papilla (i.e. transpapillary placement). A generous endoscopic sphincterotomy will be routinely performed to accommodate the stents across the papilla and to reduce the risk of pancreatitis. Endoscopic dilatation of the stricture is allowed before deployment of a stent to facilitate the insertion of stent catheters across the strictures. The crossover method (SIS to SBS, or SBS to SIS) will be attempted when bilateral drainage failed using the intended method. If the crossover method failed, only the remaining unilateral stent will be left and the patient will be closely monitored for further intervention. Percutaneous transhepatic biliary drainage or Endoscopic Ultrasound-guided biliary drainage is allowed according to patient status as reintervention or rescue therapy. Chemotherapy or radiotherapy is allowed according to the patient’s condition and with their approval after randomization. Local therapies, such as photodynamic therapy or radiofrequency ablation, will not be performed. Vital signs (heart rate, blood pressure, breathing rate, and oxygen level) will be monitored during the procedure. Clinical review bloods, and any nurse notes or clinical observations, following the procedure will be used to monitor fidelity.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
All patients who have pathologically confirmed inoperable Malignant Hilar Biliary Strictures (MHSs) of Bismuth type III or IV with an estimated survival >3 months (Eastern Cooperative Oncology Group scale, <2) will be eligible for recruitment into the study. All causes of malignancy are included. The criteria for inoperability were based on imaging studies such as Computed Tomography (CT) scan, Magnetic resonance cholangiopancreatography imaging (MRCP); cholangiography; positron emission tomography-CT; presence of comorbidities; and consensus of the surgeons.
Exclusion criteria
Uncontrolled coagulopathy, American Society of Anaesthesiologist Class V, inaccessible papilla because of an accompanying duodenal obstruction or altered anatomy, and the inability to provide informed consent. Patients with MHSs caused by multiple metastatic lesions or lobes diffusely occupied by a massive tumour were also excluded because drainage could not be performed effectively and such cases have an inherently poor survival rate.
Outcome results
None listed