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Completed

NCT Number: NCT00422409

Endoscopic Stenting of Gastrointestinal Cancer

Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.

PURPOSE:

The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.

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Key information

Conditions

Gastrointestinal Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sentral Hospital Buskerud, Drammen, Norway

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About this study

The study is divided into four projects:

  • Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
  • Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
  • Gastric emptying before/after stent will be studied.
  • Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Palliative SEMS treatment for malignant GI-obstruction in esophagus,gastroduodenal region, biliary tractus or colon
  • SEMS treatment of acute malignant colon obstruction as a bridge to surgery

Exclusion criteria

  • Not able to sign informed consent
  • SEMS placement in other location last 4 days

Treatment and study plan

Endoscopic stenting

Procedure

Primary outcomes

  1. Change/improvement i Quality of life

Secondary outcomes

  1. Need for reintervention

  2. Change/improvement in gastric emptying

  3. Rehospitalisations

  4. Complications

  5. Death

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Registry information

Official study title

Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jan 17, 2007
Registry last updated
Jul 6, 2011

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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