Endoscopic biliary drainage with multi-hole self-expandable metallic stent during neoadjuvant chemoradiotherapy in pancreatic cancer

Table 2 Clinical outcomes and adverse events, n (%)/median (range)

Outcomes		n = 14
Technical success		14 (100)
Clinical success		14 (100)
Neoadjuvant chemoradiotherapy completion		13 (92.9)
Radiotherapy protocol completion		14 (100)
Chemotherapy protocol completion		13 (92.9)
Tumor size (after neoadjuvant chemoradiotherapy), mm		20 (5-30)
Therapeutic effects based on imaging studies (RECIST)	PR	5 (35.7)
	SD	9 (64.3)
Tumor marker immediately before surgery
Carcinoembryonic antigen (ng/mL)		2.7 (0.8-10.6)
Carbohydrate antigen 19-9 (U/mL)		19 (2-87)
Duodenal pancreatic cancer antigen 2 (U/mL)		42 (25-494)
Biliary drainage–related adverse events
Pancreatitis		3 (21.4)
Grade	Mild	2 (14.3)
	Moderate	1 (7.1)
Cholecystitis		0
Nonocclusive cholangitis		0
Liver abscess		0
Hemorrhage		0
RBO
Incidence rate		1 (7.1)
Grade	Moderate	1 (7.1)
Cause	Sludge	1 (7.1)
Time to RBO (days)		337
Reintervention method	Replacement with the same MH-SEMS	1 (7.1)
Systemic chemotherapy–related adverse events (CTCAE grade ≥ 3)
GnP (n = 4)	Neutrophil count decreased	3 (75.0)
	Anemia	1 (25.0)
	Malaise	1 (25.0)
mFFX (n = 1)	Neutrophil count decreased	1 (100)
	Malaise	1 (100)
	Anorexia	1 (100)
SOXIRI (n = 2)	Neutrophil count decreased	2 (100)
	Malaise	1 (50.0)
	Diarrhea	1 (50.0)
NACRT–related adverse events (CTCAE grade ≥ 3)
Gemcitabine + IMRT (54 Gy, n = 13)	Neutrophil count decreased	3 (23.1)
	Anemia	1 (7.7)
	Malaise	1 (7.7)
Gemcitabine + S1 + IMRT (54 Gy, n = 1)	Any adverse events	0

CTCAE: Common Terminology Criteria for Adverse Events; GnP: Gemcitabine/nab-paclitaxel; IMRT: Intensity-modulated radiotherapy; mFFX: Modified FOLFIRINOX (fluorouracil/irinotecan/oxaliplatin); MH-SEMS: Multi-hole self-expandable metallic stent; NACRT: Neoadjuvant chemoradiotherapy; PR: Partial response; RBO: Recurrent biliary obstruction; RECIST: Response criteria for solid tumors; SD: Stable disease; SOXIRI: S-1/oxaliplatin/irinotecan.