Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial

Table 1 Trial events according to treatment and follow-up plan

		Intervention phase		Follow-up (time after informed consent)
Trial checkpoint	Screening	Prior to treatment	Hospital stay after inclusion	3 months (± 14 days)	6 months (± 14 days)	12 months (± 14 days)
Informed consent	X
Inclusion/exclusion criteria	X
Medical history, physical examination, vital signs	X^a	X	X^b	X	X	X
Diagnostic upper GI endoscopy		X
CT scan		X	(X)		x
ECG	X
Laboratory tests	X	X	X^b	X	X	X
Operative report		X	X
Postoperative complications, treatment failure		X	X
SOFA score		X	X^b
QoL questionnaire	X		X^c	X	X	X
Treatment costs			X
Monitoring of SAE		X (from randomization to discharge from hospital + 30 days)
Overall survival		X

^aAt inclusion with detailed medical history and extensive physical exam, otherwise only vital signs, weight, and Karnofsky index
^bOn days 3, 7, 14, and 21 (±1 day)
^cOn day 10 and prior to discharge from hospital

ISSN: 1745-6215