Skip to content

Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02166840
Acronym
SEMS
Enrollment
92
Registered
2014-06-18
Start date
2007-03-31
Completion date
2015-01-31
Last updated
2015-10-22

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

Conditions

Obstructive Jaundice, Periampullary Tumour

Brief summary

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used. Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.

Detailed description

Patients who present with obstructive jaundice and have a periampullary tumor and where the patient seems to be in good condition for surgical resection are offered the opportunity to become randomized to either endoscopic drainage with self expanding metallic or plastic stents. Before randomization they are informed about the study details and have to give their consent to participate. The metallic as well as plastic stents are standard commercially available stents. Within four weeks after stent placement the patient will be operated and the following parameters will be evaluated: quality of life, clinical symptoms and lab tests. At the operation the surgeon will make an evaluation of the inflammatory reaction in the area of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation. A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty with which the stent had to be removed. Postoperative complications are monitored in line with the regular routines at the clinic.

Interventions

PROCEDUREPlastic stent (7-10Fr)
PROCEDURESelf Expanding Metal Stent

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Obstructive jaundice in periampullary tumor.

Exclusion criteria

* Not willing to participate. * Not a resectable tumor.

Design outcomes

Primary

MeasureTime frame
Degree and amount of bile bacterial contamination at the time of resectionTime at the operation

Secondary

MeasureTime frame
Degree of inflammation around the bile duct.Time at the operative intervention
General complication ratesTime from intervention until day of discharge from hospital (on an average less than 90 days).
Postoperative hospital stay.Time from intervention until day of discharge from hospital (on an average less than 90 days).
Bacterial culture of lymph nodes in the hepatoduodenal ligament.Time of operative intervention

Countries

Sweden

Outcome results

None listed

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