Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
Condition: Biliary Disease; Common Bile Duct Calculi; Biliary Stricture; Malignant Hepatobiliary Neoplasm; Pancreatic Disease
MeSH terms: Pancreatic Diseases; Gallbladder Diseases; Gallstones; Calculi
Study type: Interventional

Summary: 
      The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the
      partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult
      biliary cannulation and to assess the incidence rate of complications between these
      cannulation methods.
    

Detailed description: 
      Cannulation success with standard techniques reported to be around 95% even in expert hands
      and despite all efforts, it can be challenging that needs an alternate intervention.

      NKF is recommended as the initial technique for pre-cutting because the rate of post-ERCP
      pancreatitis (PEP) is significantly low but there is an ongoing debate about limiting its use
      in certain types of papillae with a long intra-mural segment

      Indeed the shape of the papillae influences the success of bile duct cannulation and the
      choice of the pre-cutting technique. Type-2 and Type-3 papillae are more difficult to
      cannulate than Type-1. NKF can be performed as the initial technique for pre-cutting in
      protruded Type-2 and Type-3 papillae but it has some limitations.

      First of all, the incision can be erratic because it is performed without a guidewire and
      uncontrolled. This can cause a tattered mucosa as the incision progress and the papillae lose
      anatomic contours. Some amount of bleeding may also unavoidably occur and the field of view
      further impaired. If the initial incision line is incorrect and additional incision is
      needed, more crumpled and deformed papillae with irregular margins may be encountered. These
      undesired results are frequently experienced and prevent a clean-cut, thus further complicate
      the cannulation. Even perforation can occur.

      Recently the investigators described a novel technique, PA-EMR, for difficult biliary
      cannulation in patients with protruded Type-2, Type-3, and shar-pei papilla. The
      investigators hypothesized that with this new technique cannulation success will be higher,
      procedure time will be shorter and the adverse events will be lower versus NKF technique.
    

Intervention name(s): PA-EMR; NKF
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.; The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ERCP; cannulation; endoscopic sphincterotomy