Malignant Biliary Obstruction Clinical Trial
Official title:
Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus Endoscopic Retrograde Cholangiopancreatography for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
NCT number | NCT04898777 |
Other study ID # | MD.21.03.437 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | July 1, 2024 |
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes. Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality. The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage. The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events. Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age: 18 years and older. - Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen - Absence of duodenal obstruction. - Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL). - Histologic or cytologic diagnosis of malignancy. - Accept sharing in the study. Exclusion Criteria: - Age younger than 18 years. - Pregnancy. - Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction). - Presence of duodenal obstruction. - Histologic or cytologic diagnosis of malignancy. - Patients underwent previous intervention for biliary drainage. - Previously failed biliary cannulation at ERCP. - Prior biliary sphincterotomy or stent placement. - Surgically altered anatomy or inability to access the major duodenal papilla. - Patients unfit for anesthesia. - Patients having uncorrectable coagulopathy or thrombocytopenia. - History of allergy to radiocontrast agents. - Refuse sharing in the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Specialized Medical Hospital | Mansoura | Dakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of adverse events | - Early adverse events (within 48 hours after procedure) including: Pancreatitis, Cholangitis, Bleeding, Perforation and Peritonitis.
- Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration |
6 months | |
Secondary | Rate of technical success | Technical success is considered after successful stent placement. | During procedure | |
Secondary | Rate of clinical success | Clinical success is considered at 2 weeks if total bilirubin is less than 50 percent of baseline. | 4 weeks | |
Secondary | Procedural duration | Procedure time was defined as time from biliary cannulation to stent placement in ERCP group, and time from needle puncture of the dilated bile duct to stent placement in EUS-BD group. In cases of difficult cannulation (defined as failed biliary access within 5 min of attempt), we performed early precut fistulotomy for cannulation by experts without involvement of trainees and duodenal intubation time was not included within procedure time. | During procedure | |
Secondary | Reinterventions | Re-endoscopy in cases of stent migration, occlusion by food or tumor ingrowth. | 6 months |
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