Clinical Trials Directory

Trials / Completed

CompletedNCT03701464

Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Comparison of Clinical Efficacy Between ENGBD and PTGBD in Acute Suppurative Cholecystitis: a Single-center, Prospective Randomized Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of cholecystectomy in later stage in patients with acute suppurative cholecystitis.

Detailed description

Laparoscopic cholecystectomy was the standard surgical method for acute cholecystitis unless difficulty in resection due to acute inflammation, no improvement after supportive therapy, or early inability to tolerate cholecystectomy. In this setting, gallbladder drainage was needed. Percutaneous transhepatic gallbladder drainage (PTGBD)was used as a first-line mitigation method, whose restrictions are contraindications and strong pain caused by puncture. Endoscopic technique based on endoscopic retrograde cholangiopancreatography (ERCP) had been made another alternative management for drainage. Endoscopic drainage expanded the indications for drainage without reducing the technical success rate and clinical remission rate, especially less uncomfortable, which greatly improved the quality of life for patients. Unfortunately, because of the difficult procedures and long learning curve, endoscopic gallbladder drainage can only be performed in some large endoscopic centers. Despite a few prospective comparison of PTGBD and endoscopic ultrasound EUS drainage studies so far, there is no prospective study comparing endoscopic naso-gallbladder drainage (ENGBD) and PTGBD, especially in its impacts while cholecystectomy. This study aim to observe clinical effects of ENGBD and PTGBD during the all stage of peri-cholecystectomy.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic naso-gallbladder drainageUsing ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
PROCEDUREPercutaneous gallbladder drainagePercutaneous transhepatic technique insert drainage tube into gallbladder

Timeline

Start date
2018-10-10
Primary completion
2020-07-01
Completion
2020-07-01
First posted
2018-10-10
Last updated
2020-07-14

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03701464. Inclusion in this directory is not an endorsement.