Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Last updated: July 12, 2020
Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Overall Status: Completed

Phase

N/A

Condition

Liver Disorders

Intra-abdominal Infections

Liver Disease

Treatment

N/A

Clinical Study ID

NCT03701464
ENGBD in acute cholecystitis
  • Ages 18-90
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute suppurative cholecystitis

  • Who can not tolerate or unsuitable for cholecystectomy

Exclusion

Exclusion Criteria:

  • Unwillingness or inability to consent for the study

  • Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 /L) or using anti-coagulation drugs

  • Bile duct stones

  • Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy

  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage orperforation, severe liver disease(such as decompensated liver cirrhosis, liver failureand so on), septic shock

  • Any malignant

  • Pregnant women or breastfeeding

Study Design

Total Participants: 22
Study Start date:
October 10, 2018
Estimated Completion Date:
July 01, 2020

Study 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.

Connect with a study center

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    Lanzhou, Gansu 730000
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.