Japan Digestive Disease Week 2025
International Session (Workshop)2 (JGES, JSGE, JSGS)
October 31, 10:00–12:00, Room 11 (Portopia Hotel South Wing Topaz)
IS-W2-3_E
Re-evaluation of 6-mm-diameter covered self-expandable metal stents based on Tokyo Criteria 2024: a new option for unresectable malignant distal biliary obstruction Outstanding Award
- 1
- Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital
Background
We have long used 6-mm-diameter covered self-expandable metal stents (CSEMS) for unresectable malignant distal biliary obstruction (URMDBO) due to their safety profile. With the Tokyo Criteria 2024 revision, we reevaluated outcomes of 6-mm versus 10-mm CSEMS.
Methods
We retrospectively analyzed patients undergoing initial CSEMS placement for URMDBO. After 1:4 propensity score matching, 77 (10-mm) and 308 (6-mm) cases were selected. According to Tokyo Criteria 2024, we assessed (i)time to recurrent biliary obstruction (TRBO) and its components (stent occlusion, migration, other event (mainly, AE-related removal etc.)) using competing risk analysis, and (ii) adverse event (AE) rates.
Results
(i) The median TRBO was 244 days (10-mm) and 287 days (6-mm) (HR 0.73, P=0.12). Stent occlusion rates at 6 months were comparable (14.1% vs. 12.1%, P=0.21), whereas stent migration rates were higher (6.0% vs. 11.9%, P=0.06) and other event rate were significantly lower (16.3% vs. 4.2%, P<0.001) in 6-mm group.
(ii) The overall AE rate was lower in the 6-mm group (62.3% vs. 34.4%, P<0.001). The incidence of pancreatitis (10.8% vs. 2.9%, P<0.001) and cholecystitis (11.7% vs. 4.2%, P=0.012) were also significantly lower.
Conclusions
Although 6-mm CSEMS had a higher migration risk, it resulted in fewer AE-related removals and achieved TRBO comparable to the 10-mm CSEMS. Given its better safety profile, 6-mm CSEMS may be a option for safer stenting strategies.
We have long used 6-mm-diameter covered self-expandable metal stents (CSEMS) for unresectable malignant distal biliary obstruction (URMDBO) due to their safety profile. With the Tokyo Criteria 2024 revision, we reevaluated outcomes of 6-mm versus 10-mm CSEMS.
Methods
We retrospectively analyzed patients undergoing initial CSEMS placement for URMDBO. After 1:4 propensity score matching, 77 (10-mm) and 308 (6-mm) cases were selected. According to Tokyo Criteria 2024, we assessed (i)time to recurrent biliary obstruction (TRBO) and its components (stent occlusion, migration, other event (mainly, AE-related removal etc.)) using competing risk analysis, and (ii) adverse event (AE) rates.
Results
(i) The median TRBO was 244 days (10-mm) and 287 days (6-mm) (HR 0.73, P=0.12). Stent occlusion rates at 6 months were comparable (14.1% vs. 12.1%, P=0.21), whereas stent migration rates were higher (6.0% vs. 11.9%, P=0.06) and other event rate were significantly lower (16.3% vs. 4.2%, P<0.001) in 6-mm group.
(ii) The overall AE rate was lower in the 6-mm group (62.3% vs. 34.4%, P<0.001). The incidence of pancreatitis (10.8% vs. 2.9%, P<0.001) and cholecystitis (11.7% vs. 4.2%, P=0.012) were also significantly lower.
Conclusions
Although 6-mm CSEMS had a higher migration risk, it resulted in fewer AE-related removals and achieved TRBO comparable to the 10-mm CSEMS. Given its better safety profile, 6-mm CSEMS may be a option for safer stenting strategies.
- Index Term 1: Malignant biliary obstruction
- Index Term 2: Safety drainage