Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis

Success Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701464
• Other study ID #: ENGBD in acute cholecystitis
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ?, 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

Related Conditions & MeSH terms

• Cholecystitis
• Success Rate

Intervention

Procedure:
• Endoscopic naso-gallbladder drainage
Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
• Percutaneous gallbladder drainage
Percutaneous transhepatic technique insert drainage tube into gallbladder

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (4)

Itoi T, Kawakami H, Katanuma A, Irisawa A, Sofuni A, Itokawa F, Tsuchiya T, Tanaka R, Umeda J, Ryozawa S, Doi S, Sakamoto N, Yasuda I. Endoscopic nasogallbladder tube or stent placement in acute cholecystitis: a preliminary prospective randomized trial in Japan (with videos). Gastrointest Endosc. 2015 Jan;81(1):111-8. doi: 10.1016/j.gie.2014.09.046. — View Citation

Jang JW, Lee SS, Song TJ, Hyun YS, Park DY, Seo DW, Lee SK, Kim MH, Yun SC. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051. Epub 2012 Jan 11. — View Citation

Kedia P, Sharaiha RZ, Kumta NA, Widmer J, Jamal-Kabani A, Weaver K, Benvenuto A, Millman J, Barve R, Gaidhane M, Kahaleh M. Endoscopic gallbladder drainage compared with percutaneous drainage. Gastrointest Endosc. 2015 Dec;82(6):1031-6. doi: 10.1016/j.gie.2015.03.1912. Epub 2015 May 5. — View Citation

Khan MA, Atiq O, Kubiliun N, Ali B, Kamal F, Nollan R, Ismail MK, Tombazzi C, Kahaleh M, Baron TH. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87.e3. doi: 10.1016/j.gie.2016.06.032. Epub 2016 Jun 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain remission(visual-analogue scale)	Pain assessment would be performed using the visual-analogue scale after procedures. Draw a 10 cm line on a piece of paper, mark one end of the line with the nubmer 0, indicating no pain; the other end with 10, indicating severe pain; the middle part indicates different degrees of pain. While assesing the pain scale, make sure the patient can not see the numbers on the paper, and let them mark the position according to their feelings about the pain. And the physician will have a score based on the mark.	3 weeks
Secondary	Gallbladder drainage success rate	Bile juice outflow more than 50ml a day	3 months
Secondary	Migration	Number of participants with tube dislocation from gallbladder	3 months
Secondary	Hemorrhage	Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention	3 months
Secondary	Perforation	Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas	3 months
Secondary	Bile leak	Number of participants with bile juice leak into abdomen	3 months
Secondary	Number of participants with Pancreatitis	Was defined as typical pain, Serum amylase at least three times than normal after EPCP	3 months
Secondary	Cholecystectomy duration	Time of laparoscopic cholecystectomy	3 months
Secondary	Hemorrhage during cholecystectomy	The amount of bleeding	3 months