Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis (TENSION). Long-term outcomes of a step-up endoscopic versus surgical step-up approach

Acute pancreatitis is the most common gastrointestinal diagnosis requiring
hospital admission. Most patients experience a mild clinical course and can be
managed with fluid resuscitation and pain control. Approximately 20% of
patients develop a severe pancreatitis with necrosis of the (peri)pancreatic
tissue. According to the evidence based international guidelines, suspected or
proven infected necrosis is an indication for invasive intervention in patients
who clinically deteriorate.
During the last decades, the management of infected necrotizing
pancreatitis developed from open necrosectomy to a minimally invasive step-up
approach. The TENSION trial compared endoscopic step-up approach to surgical
step-up approach in these patients and showed that there was no difference in
mortality and major morbidity between the endoscopic and minimally invasive
surgical approach. However, the endoscopic approach resulted in a shorter
hospital stay and reduced costs.
These results resulted in a shift to the endoscopic step-up approach as the
preferred treatment strategy. It is however unclear whether these patients
underwent additional interventions in the period beyond the original follow-up
period (i.e. the first 6 months after discharge). Moreover, the incidence of
long-term complications such as pancreatic exocrine and endocrine insufficiency
and impact of quality of life on patients with necrotizing pancreatitis may
differ between the endoscopically and surgically treated patients.

Primary Objective:
In accordance with the original study, the primary endpoint is composite of
mortality and major morbidity. Major morbidity is defined as new onset organ
failure (cardiac, pulmonary or renal), bleeding requiring intervention,
perforation of a visceral requiring intervention, enterocutaneous fistula
requiring intervention and incisional hernia.

Secondary Objective(s):
Secondary endpoints are the individual components of the primary endpoint,
other morbidity such as pancreaticocutaneous fistula, exocrine and/or endocrine
pancreatic insufficiency, development of additional fluid collections requiring
intervention, biliairy strictures, wound infections, the need for necrosectomy
(either endoscopically or surgically), the total number of surgical, endoscopic
or radiological (re-) interventions, total length of intensive care- and
hospital stay, quality of life, costs per patient with poor outcome, costs per
QALY, total direct and indirect medical costs and the total number of
cross-over between groups.

Observational long term follow-up cohort study of patients with (suspected or
confirmed) infected necrotizing pancreatitis who were randomized in the TENSION
trial and were therefore received the endoscopic or surgical step-up approach.

The risk for the patient is vanishingly small