Symptoms and General Pathology

All Conditions

Digestive System Diseases

Constriction, Pathologic

Calculi

Pancreatic Diseases

Gallbladder Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Pathological Conditions, Anatomical

Gastrointestinal Diseases

Biliary Tract Diseases

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.

PA-EMR

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.

Salih Tokmak, Assist. prof

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.

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.

Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation

Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.

Time from first contact with cannula to papillae to deep cannulation

Cukurova University

Duzce University

Asisstant Professor

Neoplasms

Dilatation, Pathologic

Bile Duct Diseases

Bile Duct Neoplasms

Common Bile Duct Neoplasms

Common Bile Duct Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.

Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.

An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.

Dexamethasone 4mg

Muhammad Nabeel Shafqat

Najam us Sehar Saeed, FCPS

Najam us Sehar Saeed, FCPS-Gastro

The main aim of this clinical trial is to evaluate the effects of dexamethasone on common bile duct cannulation time during endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary pathologies. The study will also study the effects of dexamethasone on total procedure time and total fluoroscopy time during ERCP.

Participants will be divided into two groups, treatment group and placebo group. Patients in treatment group will receive dexamethasone and those in placebo group will be given normal saline before undergoing ERCP. The results in both groups will be compared to determine the effects of dexamethasone.

Effects of Dexamethasone on Common Bile Duct Cannulation Time

Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone

To determine the effects of dexamethasone on shortening of CBD cannulation time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation	NCT05068739	Biliary Disease Common Bile Duc... Biliary Strictu... Malignant Hepat... Pancreatic Dise...	PA-EMR NKF	16 Years - 90 Years	Duzce University
Effects of Dexamethasone on Common Bile Duct Cannulation Time	NCT05945797	Common Bile Duc... Common Bile Duc... Common Bile Duc... Common Bile Duc... Common Bile Duc...	Dexamethasone 4...	18 Years -	Gujranwala medical college District Headquarters Hospital, Gujranwala
Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation	NCT05068739	Biliary Disease Common Bile Duc... Biliary Strictu... Malignant Hepat... Pancreatic Dise...	PA-EMR NKF	16 Years - 90 Years	Duzce University
Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation	NCT05068739	Biliary Disease Common Bile Duc... Biliary Strictu... Malignant Hepat... Pancreatic Dise...	PA-EMR NKF	16 Years - 90 Years	Duzce University

Spots Global Cancer Trial Database for common bile duct calculi