Definitions
death, ischaemic stroke, stricture, multi-organ dysfuncton, single-organ dysfunction, TIAs
SUBARACHNOID HAEMORRHAGE, ISCHAEMIC STROKE, ADVERSE EVENTS, ADVERSE EVENT, EVENT, EVENTS, BLOOD, CNS COMPLICATION, STRICTURE, BRAIN HAEMORRHAGE, TRANSIENT ISCHAEMIC ATTACKS, DILATION, COMPLICATIONS, COMPLICATIONS
Technical success for endoscopic treatment is defined, for EBD and FCSEMS placement, as follows: for the former if the endoscope passes through the stricture after dilation, and for the latter the ability to place the stent on the stricture.The success of the surgical technique is defined as the ability to perform the planned surgery.AEs will be recorded in both the patient’s medical record and the electronic data collection tool using the appropriate medical terminology. Whenever possible, the diagnosis rather than the symptoms will be recorded. All AEs will be recorded once the informed consent has been signed and until 30 days after the last study visit. The study promoter/principal investigator will report all serious AEs within 7 days. In the event of a death, notification will be made within 24 h. Any instances of death during the follow-up will be investigated to rule out possible relation to the endoscopic or surgical treatment. Complications will be handled and treated in accordance with the decisions of the patient’s medical team. All additional tests and interventions will be duly documented.The AEs for endoscopic treatment will be classified according to the AGREE classification [AGREE Classification for adverse events in GI endoscopy • A telephone contact with the general practitioner, outpatient clinic, or endoscopy service without any intervention or • Extended observation of the patient after the procedure, <3 hours, without any interventionAdverse events with any deviation of the standard postprocedural course, without the need for pharmacologic treatment or endoscopic, radiologic, or surgical interventions. • Presentation at the emergency ward, without any intervention or • Hospital admission (<24 hours), without any intervention or • Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, and electrolytes or • Allowed diagnostic tests: radiology and laboratory tests • Adverse events requiring pharmacologic treatment with drugs other than those allowed for grade I adverse events (ie, antibiotics, antithrombotics, etc) or • Blood or blood product transfusions or • Hospital admission for more than 24 hoursClassification of surgery complications; Clavien-Dindo IIIaComplications requiring surgical, endoscopic, or radiological intervention Grade IIIa—intervention not under general anesthetic Grade IIIb—intervention under general anestheticLife-threatening complications: this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade IVa—single-organ dysfunction (including dialysis) Grade IVb—multi-organ dysfuncton