Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Constriction, Pathologic

Jaundice

Hyperbilirubinemia

Skin Manifestations

Pancreatic Cancer

Bile Duct Cancer

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice.

The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.

The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.

However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)

Rate of resolution of obstructive jaundice in short and long term (i.e. maintenance of patency and/or the need for reintervention) of the different types of biliary stent placed in patients with neoplastic stenosis of the common bile duct

Rate of periprocedural complications (i.e. bleeding, pancreatitis, cholecystitis) after biliary stent placement

Rate of stent disfunction requiring an additional endoscopic procedure

Rate of biliary cannulation and successful stent placement

Azienda Unità Sanitaria Locale della Romagna

Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals

Calculi

Dilatation, Pathologic

Bile Duct Diseases

Bile Duct Neoplasms

Common Bile Duct Neoplasms

Common Bile Duct Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Pathological Conditions, Anatomical

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gallbladder Diseases

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

Gujranwala medical college District Headquarters Hospital, Gujranwala

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)	NCT05395013	Common Bile Duc... Jaundice; Malig...		18 Years -	Azienda Unità Sanitaria Locale della Romagna
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)	NCT05395013	Common Bile Duc... Jaundice; Malig...		18 Years -	Azienda Unità Sanitaria Locale della Romagna
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

Spots Global Cancer Trial Database for common bile duct stricture