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

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

Study Overview

• Status: Completed
• Conditions: Success Rate
• Intervention / Treatment: Procedure: Endoscopic naso-gallbladder drainage; Procedure: Percutaneous gallbladder drainage

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Endoscopic naso-gallbladder drainage; Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
ACTIVE_COMPARATOR: 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.	Procedure: Percutaneous gallbladder drainage; Percutaneous transhepatic technique insert drainage tube into gallbladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder drainage success rate	Bile juice outflow more than 50ml a day	3 months
Migration	Number of participants with tube dislocation from gallbladder	3 months
Hemorrhage	Number of participants with bleeding which was defined as hemoglobin deceased, or required transfusion or additional intervention	3 months
Perforation	Number of participants whose CT scan shows retroperitoneal or gallbladder space fluid or gas	3 months
Bile leak	Number of participants with bile juice leak into abdomen	3 months
Number of participants with Pancreatitis	Was defined as typical pain, Serum amylase at least three times than normal after EPCP	3 months
Cholecystectomy duration	Time of laparoscopic cholecystectomy	3 months
Hemorrhage during cholecystectomy	The amount of bleeding	3 months

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Mu P, Lin Y, Zhang X, Lu Y, Yang M, Da Z, Gao L, Mi N, Li T, Liu Y, Wang H, Wang F, Leung JW, Yue P, Meng W, Zhou W, Li X. The evaluation of ENGBD versus PTGBD in high-risk acute cholecystitis: A single-center prospective randomized controlled trial. EClinicalMedicine. 2020 Dec 23;31:100668. doi: 10.1016/j.eclinm.2020.100668. eCollection 2021 Jan.
• Mu P, Yue P, Li T, Bai B, Lin Y, Zhang J, Wang H, Liu Y, Yao J, Meng W, Li X. Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19116. doi: 10.1097/MD.0000000000019116.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2018
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; Cholecystitis; PTGBD; ENGBD; Gallbladder drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis
• Other Study ID Numbers: ENGBD in acute cholecystitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No