Gastric Outlet Obstructions Tailored Covered Stents for GOO

NCT02299258 | Completed Results DMC

• 1 other identifier: 2011ZHE008
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

Conditions

Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• Efficiency of Stents

  number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study

  up to 5 years

Secondary Outcomes (1)

• Adverse Events

  up to 5 years

Study Arms (2)

Tailored stents MTN-WE-20/100-A

ACTIVE COMPARATOR

The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.

Device: Tailored stents MTN-WE-20/100-A

Standard stents MTN-CG-s-20/100

EXPERIMENTAL

Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm

Device: Standard stents MTN-CG-s-20/100

Interventions

Standard stents MTN-CG-s-20/100 DEVICE

The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm

Standard stents MTN-CG-s-20/100

Tailored stents MTN-WE-20/100-A DEVICE

cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.

Tailored stents MTN-WE-20/100-A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb

You may not qualify if:

• the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.

Sponsors & Collaborators

• The First People's Hospital of Yuhang District: lead

Study Sites (1)

The First People's Hospital of Yuhang District

Hangzhou, China

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr.Ding Shi
• Organization: The First People's Hospital of Yuhang District

shidingyuhang@163.com

+8657189369162

Study Officials

• Ding Shi

  The First People's Hospital of Yuhang District

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: May 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 12, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-02

Locations

CN (1)