PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Table 5 Expected and unexpected events for serious adverse event (SAE) reporting

Expectedness	Event	Grade 3 and below		Grade 4 and above
Expectedness	Event	Report as SAE	Subject to expedite reporting	Report as SAE	Subject to expedite reporting
Expected	Pancreatic fistula (graded as A, B or C)	No	No	Yes	No
	Delayed gastric emptying (graded as A, B, or C)	No	No	Yes	No
	Wound infections	No	No	Yes	No
	Pulmonary Infection	No	No	Yes	No
	Post-operative fluid collection	No	No	Yes	No
	Intra- and post-operative bleeding	No	No	Yes	No
	Re-operation	No	No	Yes	No
	Venous thromboembolism	No	No	Yes	No
	Interventional drainage procedures	No	No	Yes	No
	Extended hospital stay due to delayed surgery	No	No	Yes	No
	Surgical complication related hospital stay	No	No	Yes	No
	New post-operative pancreatic exocrine and or endocrine failure	Yes	No	Yes	No
Unexpected	Any other serious event deemed to be unrelated to the surgical intervention	Yes	No	Yes	No
Unexpected	Any other serious event deemed to be related to the surgical intervention	Yes	Yes	Yes	Yes

ISSN: 1745-6215