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Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

NCT00004910•Northwestern University

View on ClinicalTrials.gov

Summary

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery. PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Detailed Description

OBJECTIVES: * Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents. * Evaluate the efficacy and safety of this treatment in these patients. * Evaluate the quality of life of these patients after enteral Wallstent placement. OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum. Quality of life is assessed at 48 hours and 6 months after procedure. Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Endoscopically confirmed localized tumor as the cause of duodenal obstruction
•* All primary tumor types are eligible
•No prior duodenal Wallstents
•Must have symptoms of gastrointestinal obstruction, including:
•* Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea
•PATIENT CHARACTERISTICS:
•Age:
•18 and over
•Performance status:
+19 more criteria

Exclusion Criteria

•PRIOR CONCURRENT THERAPY:
•Biologic therapy:
•Not specified
•Chemotherapy:
•Prior or concurrent chemotherapy allowed
•Endocrine therapy:
•Not specified
•Radiotherapy:
•Prior or concurrent radiotherapy allowed
•Surgery:
+1 more criteria

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

January 1, 2000

Primary Completion Date

February 1, 2003

Completion Date

February 1, 2003

Last Updated

June 6, 2012

Conditions

Colorectal CancerConstipation, Impaction, and Bowel ObstructionExtrahepatic Bile Duct CancerGastric CancerGastrointestinal Carcinoid TumorGastrointestinal Stromal TumorPancreatic CancerQuality of LifeSmall Intestine Cancer

Interventions

bowel obstruction management

PROCEDURE

quality-of-life assessment

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease