Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422409
Other study ID # 672
Secondary ID
Status Completed
Phase N/A
First received January 16, 2007
Last updated July 3, 2011
Start date October 2006
Est. completion date April 2010

Study information

Verified date April 2007
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

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.


Description:

The study is divided into four projects:

1. 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.

2. 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.

3. Gastric emptying before/after stent will be studied.

4. Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date April 2010
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Endoscopic stenting


Locations

Country Name City State
Norway Sentral Hospital Buskerud Drammen
Norway Sentral Hospital Østfold Fredrikstad
Norway Sykehuset Innlandet Gjøvik Gjøvik
Norway Sykehuset Innlandet Lillehammer Lillehammer
Norway AHUS University Hospital Oslo
Norway Aker University Hospital Oslo
Norway Ullevaal University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change/improvement i Quality of life
Secondary Need for reintervention
Secondary Change/improvement in gastric emptying
Secondary Rehospitalisations
Secondary Complications
Secondary Death
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Completed NCT05178095 - Artificial Intelligence in Colonic Polyp Detection N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT02871245 - Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery N/A
Completed NCT04694521 - Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial N/A
Not yet recruiting NCT02860429 - Clinical Trial of Cinobufacini Injection Combined With Oxaliplatin Regimen on Gastrointestine Carcinoma Phase 4
Completed NCT02454647 - Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients N/A
Recruiting NCT02196935 - Los Angeles Prospective GI Biliary and EUS Series
Completed NCT00190801 - Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma Phase 2
Completed NCT00289445 - Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment) Phase 1/Phase 2
Completed NCT04010227 - Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers N/A
Recruiting NCT03330964 - Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity N/A
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Recruiting NCT05322486 - Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
Completed NCT03549494 - Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction Phase 2
Completed NCT03559543 - Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma Phase 2
Recruiting NCT02672774 - Novel Endoscopic Imaging Methods for the Evaluation of Blood Vessels in Gastrointestinal Cancers N/A
Completed NCT02444572 - Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox® Phase 4