Dataset Information

Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant).

ABSTRACT: INTRODUCTION:Transitional drainage, which is followed by cholecystectomy plays a key role in the management of acute cholecystitis, especially in high-risk surgical patients. Endoscopic naso-gallbladder drainage (ENGBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients who need temporary drainage. There is a lack of prospective comparison on the relevant outcomes of the two drainage methods during the period of drainage, especially the subsequent cholecystectomy. METHODS:This is a randomized controlled two-arm non-blind single center trial. Patients with acute cholecystitis undergo emergent or early cholecystectomy and need drainage will be randomly assigned to group PTGBD or ENGBD. Pain score is defined as the primary endpoint, whereas several secondary endpoints, such as the rates of technical success, clinical remission, open conversion of cholecystectomy will be determined to elucidate more detailed differences between two groups. The general feasibility, safety, and quality checks required for high-quality evidence will be adhered to. DISCUSSION:This study would provide the first type A evidence concerning the comparison of ENGBD versus PTGBD in surgically high-risk patients with acute cholecystitis, it will be the first trial designed to determine the impact of two drainage methods on not only peri-drainage but also peri-LC. TRIAL REGISTRATION:NCT03701464. Registered on October 10, 2018.

SUBMITTER: Mu P

PROVIDER: S-EPMC7034714 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant).

Mu Peilei P Yue Ping P Li Tianya T Bai Bing B Lin Yanyan Y Zhang Jinduo J Wang Haiping H Liu Ying Y Yao Jia J Meng Wenbo W Li Xun X

Medicine 20200201 8

<h4>Introduction</h4>Transitional drainage, which is followed by cholecystectomy plays a key role in the management of acute cholecystitis, especially in high-risk surgical patients. Endoscopic naso-gallbladder drainage (ENGBD) is an alternative to percutaneous transhepatic gallbladder drainage (PTGBD) for patients who need temporary drainage. There is a lack of prospective comparison on the relevant outcomes of the two drainage methods during the period of drainage, especially the subsequent ch ...[more]

PMID: 32080085

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Project description:BackgroundSevere adhesions and fibrosis between the posterior wall of the gallbladder and liver bed often render total cholecystectomy after percutaneous transhepatic gallbladder drainage (PTGBD) difficult, leading to high open conversion rates. Since the publication of Tokyo Guidelines 2018 (TG18), our policy has shifted from open conversion to subtotal cholecystectomy (SC) when total laparoscopic cholecystectomy for difficult cases of cholecystitis is not feasible. Recently, SC has been frequently applied as bailout surgery for complicated cholecystitis. Nonetheless, the efficacy and validity of laparoscopic SC after PTGBD remain unclear. This study aimed to evaluate the safety and feasibility of laparoscopic SC after PTGBD for grade II or III acute cholecystitis (AC) by comparing two periods of altered surgical strategies.MethodsThis retrospective cohort study was conducted between January 2013 and December 2020. A total of 44 eligible patients with grade II or III AC were divided according to the time of cholecystitis onset into the pre-TG18 group (2013-2017, n = 17) and post-TG18 group (2018-2020, n = 27). Patients' background demographics, surgical method, surgical results, and postoperative complications were compared.ResultsThe interval between PTGBD and surgery was significantly longer in the post-TG18 group than in the pre-TG18 group (15 [interquartile range: 9-42] days vs. 8 [4-11] days; P = 0.010). The frequency of laparoscopic cholecystectomy significantly increased from 52.9% in the pre-TG18 group to 88.9% in the post-TG18 group (P = 0.007), whereas the frequency of SC was 23.5% and 40.7%, respectively, which showed no statistically significant difference (P = 0.241). However, the rate of laparoscopic SC significantly increased from 0 to 90.9% among 15 SC cases, whereas the rate of open SC significantly plummeted from 100 to 9.1% (P = 0.001). Significant differences in the operative time, amount of intraoperative bleeding, and incidence of postoperative complications (wound infection and subhepatic abscess) were not observed. Mortality, bile leakage, and bile duct injury did not occur in either group.ConclusionsFor grade II or III AC after PTGBD, aggressive adoption of SC increased the completion rate of laparoscopic surgery. Laparoscopic SC is a safe and feasible treatment option.

Project description:Background and study aims Preoperative biliary drainage of hilar cholangiocarcinoma (HC) is controversial. The goal of this study was to compare the clinical outcome and associated complications for types II, III, and IV HC managed by percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP). Patients and methods Between January 2011 and June 2017, a total of 180 patients with II, III, and IV HC were enrolled in this retrospective cohort study. According to the drainage method, patients were divided into two groups: PTBD (n = 81) and ERCP (n = 99). This study was registered with ClinicalTrials.gov, NCT03104582, and was completed. Results Compared with the PTBD group, the ERCP group had a higher incidence of post-procedural cholangitis (37 [37.37 %] vs. 18 [22.22 %], P = 0.028) and pancreatitis (17 [17.17 %] vs. 2 [2.47 %], P = 0.001); required more salvaged biliary drainage (18 [18.18 %] vs. 5 [6.17 %], P = 0.029), and incurred a higher cost ( P < 0.05). Patients with type III and IV HC in the ERCP group had more cholangitis than those in the PTBD group (26 [36.62 %] vs. 11 [18.03 %], P = 0.018). The rate of cholangitis in patients who received endoscopic bilateral biliary stents insertion was higher than patients with unilateral stenting (23 [50.00 %] vs. 9 [26.47 %], P = 0.034), and underwent PTBD internal-external drainage had a higher incidence of cholangitis than those with only external drainage (11 [34.36 %] vs. 7 [14.29 %], P = 0.034). No significant difference in the rate of cholangitis was observed between the endoscopic unilateral stenting group and the endoscopic nasobiliary drainage group (9 [26.47 %] vs. 5 [26.32 %], P = 0.990). Conclusion Compared to ERCP, PTBD reduced the rate of cholangitis, pancreatitis, salvage biliary drainage, and decreased hospitalization costs in patients with types II, III, and IV HC. Risk of cholangitis for patients with types III and IV was significantly lower in the PTBD group.

Dataset Information

Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant).

Publications

Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant).

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