Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2020-07-01

Brief Summary

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

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Detailed Description

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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

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Success Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endoscopic naso-gallbladder drainage

After selective bile duct cannulation, a 0.025- or 0.035-inch guidewire is advanced into the cystic duct and subsequently into the gallbladder. A 5F naso- Pancreas catheter was inserted into the gallbladder for ENGBD.

Group Type EXPERIMENTAL

Endoscopic naso-gallbladder drainage

Intervention Type PROCEDURE

Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.

Percutaneous gallbladder drainage

Ultrasound guided，an 18-gauge needle is inserted into the gallbladder，0.035 inch guidewire is coiled into the gallbladder and 9Fr dilator expands the skin,then 8Fr-20cm catheter is placed.

Group Type ACTIVE_COMPARATOR

Percutaneous gallbladder drainage

Intervention Type PROCEDURE

Percutaneous transhepatic technique insert drainage tube into gallbladder

Interventions

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Endoscopic naso-gallbladder drainage

Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.

Intervention Type PROCEDURE

Percutaneous gallbladder drainage

Percutaneous transhepatic technique insert drainage tube into gallbladder

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute suppurative cholecystitis
* Who can not tolerate or unsuitable for cholecystectomy

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 or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
* Any malignant
* Pregnant women or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No