WithdrawnPhase 2

Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Stopped: Withdrawn

Sweden0Started 2007-03

Plain-language summary

Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction. * The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable". Exclusion Criteria: * Non consent. * The patients' general condition will not tolerate either treatment (strategy). * Previous laparotomy or laparoscopy. * Life expectancy \< 3 months. * Inability to participate (language, social, etc.)

What they're measuring

Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.

Timeframe: 1, 3 and 6 months

Trial details

NCT IDNCT00487851

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

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