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OpenTrials
Completed

NCT Number: NCT02166840

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital

Stockholm, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructive jaundice in periampullary tumor.

Exclusion criteria

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

Treatment and study plan

Plastic stent (7-10Fr)

Procedure

Self Expanding Metal Stent

Procedure

Primary outcomes

  1. Degree and amount of bile bacterial contamination at the time of resection

    Time frame: Time at the operation

Secondary outcomes

  1. Degree of inflammation around the bile duct.

    Time frame: Time at the operative intervention

  2. General complication rates

    Time frame: Time from intervention until day of discharge from hospital (on an average less than 90 days).

  3. Postoperative hospital stay.

    Time frame: Time from intervention until day of discharge from hospital (on an average less than 90 days).

  4. Bacterial culture of lymph nodes in the hepatoduodenal ligament.

    Time frame: Time of operative intervention

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: SEMS

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Jun 18, 2014
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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