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

Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487851

Enrollment

Registered

2007-06-19

Start date

2007-03-31

Completion date

2012-12-31

Last updated

2013-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms, Duodenal Neoplasms, Pancreatic Neoplasms

Keywords

Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction, pancreas cancer, Pancreatic cancer

Brief summary

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

Detailed description

Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Interventions

PROCEDUREsurgery

hepaticojejunostomy and gastroenterostomy

PROCEDUREendoscopic strategy

Stent insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame
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.	1, 3 and 6 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026