Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of cholecystectomy in later stage in patients with acute suppurative cholecystitis.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic naso-gallbladder drainage | Experimental | 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. |
|
| Percutaneous gallbladder drainage | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic naso-gallbladder drainage | Procedure | Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xun Li, MD,PhD | Hepatopancreatobiliary Surgery Institute of Gansu Province | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22245666 | Background | 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. | |
| 25952093 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percutaneous gallbladder drainage | Procedure | Percutaneous transhepatic technique insert drainage tube into 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 |
| 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. |
| 25527052 | Background | 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. |
| 27343412 | Background | 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. |
| 33385126 | Derived | 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. |
| 32080085 | Derived | 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. |