Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: a multicentre, randomised controlled trial (Coelen 2018)
N = 54
- Population
- Adults with potentially resectable perihilar cholangiocarcinoma requiring major liver resection, with bilirubin above 50 μmol/L in the future liver remnant; 54 eligible patients randomised.
- Design
- Multicentre randomised controlled trial at four academic centres in the Netherlands. Patients aged at least 18 with potentially resectable perihilar cholangiocarcinoma requiring major liver resection and biliary obstruction of the future liver remnant (bilirubin above 50 μmol/L [2.9 mg/dL]) were randomly assigned 1:1 by computer-generated allocation to endoscopic biliary drainage or percutaneous transhepatic biliary drainage, stratified for previous (attempted) biliary drainage, extent of bile duct involvement and centre. 261 patients were screened and 54 randomised between 26 September 2013 and 29 April 2016. Primary outcome: the number of severe complications between randomisation and surgery, intention-to-treat population. The study was closed prematurely because of higher mortality with percutaneous transhepatic drainage. Registered NTR4243 (Netherlands National Trial Register); no ClinicalTrials.gov number is given in the abstract. The abstract names neither arm as the control; the control and experimental roles shown are assigned only because the schema requires them (endoscopic drainage is the reference arm for the reported relative risks).
- Arms
- Endoscopic biliary drainage (control, n = 27): Endoscopic biliary drainage before surgery
- Percutaneous transhepatic biliary drainage (experimental, n = 27): Percutaneous transhepatic biliary drainage before surgery
- People
- Coelen RJS
Δ Severe drainage-related complications before surgery−4 pointsΔ All-cause mortality+30 points
Show the numbers
| Endpoint | Analysis | Percutaneous transhepatic biliary drainage | Endoscopic biliary drainage | Effect |
|---|---|---|---|---|
| Severe drainage-related complications before surgery | primaryCoelen 2018 | 63% | 67% | Severe preoperative drainage-related complications in 17 (63%) of 27 patients with percutaneous transhepatic drainage and 18 (67%) of 27 with endoscopic drainage; relative risk 0.94 (95% CI 0.64-1.40), percutaneous relative to endoscopic. Preoperative cholangitis: 16 (59%) vs 10 (37%), p=0.1. Additional percutaneous drainage was needed after endoscopic drainage in 15 (56%) patients, whereas 1 (4%) needed endoscopic drainage after percutaneous drainage. |
| All-cause mortalityAll 54 randomised patients (27 per group); the abstract states intention-to-treat only for the primary outcomeDeaths among randomised patients up to the time the study was closed. | finalCoelen 2018 | 41% | 11% | P=0.03Deaths in 11 (41%) of 27 patients with percutaneous transhepatic drainage and 3 (11%) of 27 with endoscopic drainage; relative risk 3.67 (95% CI 1.15-11.69). This difference was the reason for premature closure; it was not the primary outcome. Three of the 11 deaths in the percutaneous group occurred before surgery. The authors advise cautious interpretation because of the small sample. |
| Endpoint | Analysis | Percutaneous transhepatic biliary drainage | Endoscopic biliary drainage | Effect |
|---|---|---|---|---|
| Severe drainage-related complications before surgery | primaryCoelen 2018 | 63% | 67% | Severe preoperative drainage-related complications in 17 (63%) of 27 patients with percutaneous transhepatic drainage and 18 (67%) of 27 with endoscopic drainage; relative risk 0.94 (95% CI 0.64-1.40), percutaneous relative to endoscopic. Preoperative cholangitis: 16 (59%) vs 10 (37%), p=0.1. Additional percutaneous drainage was needed after endoscopic drainage in 15 (56%) patients, whereas 1 (4%) needed endoscopic drainage after percutaneous drainage. |
| All-cause mortalityAll 54 randomised patients (27 per group); the abstract states intention-to-treat only for the primary outcomeDeaths among randomised patients up to the time the study was closed. | finalCoelen 2018 | 41% | 11% | P=0.03Deaths in 11 (41%) of 27 patients with percutaneous transhepatic drainage and 3 (11%) of 27 with endoscopic drainage; relative risk 3.67 (95% CI 1.15-11.69). This difference was the reason for premature closure; it was not the primary outcome. Three of the 11 deaths in the percutaneous group occurred before surgery. The authors advise cautious interpretation because of the small sample. |