Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
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|ClinicalTrials.gov Identifier: NCT05068739|
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Biliary Disease Common Bile Duct Calculi Biliary Stricture Malignant Hepatobiliary Neoplasm Pancreatic Disease||Procedure: PA-EMR Procedure: NKF||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: PA-EMR (Partial ampullary endoscopic mucosal resection)
Partial ampullary endoscopic mucosal resection
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.
Active Comparator: NKF(Needle knife fistulotomy)
Needle knife fistulotomy
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.
- Success rate of cannulation [ Time Frame: 1 day ]Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.
- Incidence rate of complications [ Time Frame: 1 week ]The rate of complications (if any occur)
- Cannulation time [ Time Frame: 1 day ]Time from first contact with cannula to papillae to deep cannulation
- Procedure time [ Time Frame: 1 day ]Total procedure time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068739
|Contact: Salih Tokmak, Asisst. prof||05052532668 ext firstname.lastname@example.org|
|Duzce University School of Medicine||Recruiting|
|Duzce, Turkey, 81620|
|Contact: Salih Tokmak +905052532698 email@example.com|
|Study Director:||Salih Tokmak, Assist. prof||Duzce University|