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EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.

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ClinicalTrials.gov Identifier: NCT03823690
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

Brief Summary:

Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is associated with a high success and low re-intervention rates, there is a risk of morbidities (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic stent (SEMS) is an alternative to surgery for the palliating these patients. As compared to surgery, the procedure is associated with shorter hospital stay, reduced morbidities and cost. However, the clinical efficacy of SEMS is limited by several problems. In uncovered SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered SEMS, stent migration occurs at a frequency of 14-25% and it is a major obstacle to stent patency. As a result, randomized trials comparing uncovered stents and partially or fully covered stents in patients with malignant GOO have reported comparable stent patency between the two types of stents.

Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using lumen-apposing stents has been described. The procedure was associated with a technical success rate of around 90% and clinical success of 85% to 100%. The procedure holds the potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of re-intervention. We have previously published a novel method of creating EUS-GJ with the use of a double balloon occluder (EPASS). The device provides a stable condition for performance of EUS-GJ and improves the safety of the procedure. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS and DS under a randomized setting.


Condition or disease Intervention/treatment Phase
Gastric Outlet Obstruction Device: EUS-guided gastrojejunstomy Device: The pyloro-duodenal stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients would be randomized to either EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) or uncovered duodenal stent after cannulation of the obstruction site is achieved with the guide-wire.
Masking: Single (Participant)
Masking Description: Recruited patients would not be informed of the type of treatment that was received.
Primary Purpose: Treatment
Official Title: EUS-guided Balloon-occluded Gastrojejunostomy Bypass (EPASS) Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Active Comparator: EUS-guided gastrojejunostomy

The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated.

A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.

Device: EUS-guided gastrojejunstomy
As listed in the arms description
Other Name: EPASS

Active Comparator: Pyloro-duodenal stent
The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.
Device: The pyloro-duodenal stent
As listed in the arms description
Other Name: DS




Primary Outcome Measures :
  1. Re-intervention rate [ Time Frame: 6 months ]
    The percentage of patients requiring additional endoscopic intervention due to stent dysfunction.


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: 1 day ]
    The successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy.

  2. Clinical success rate [ Time Frame: 3 days ]
    Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within 3 days after stent insertion.

  3. Stent dysfunction rate [ Time Frame: 6 months ]
    Stent dysfunction is defined as the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture.

  4. Duration of stent patency [ Time Frame: 6 months ]
    Calculated from the time of stent placement to the time of stent dysfunction.

  5. Adverse events rate [ Time Frame: 6 months ]
    Graded according to the lexicon of endoscopic adverse events

  6. Mortality [ Time Frame: 6 months ]
    Death from any cause

  7. Gastric outlet obstruction scores (GOOS) [ Time Frame: 6 months ]
    Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet

  8. Quality of life assessment scores [ Time Frame: 6 months ]
    EORTC QLQ-C30. This questionnaire is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  9. Quality of life assessment scores [ Time Frame: 6 months ]
    EORTC STO-22 modules. This the gastric cancer module to the QLQ-C30 questionnaire. The questionnaire is composed of 5 multiitem scales (dysphagia, pain, reflux, eating, anxiety) and 4 single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients ≥ 18 years old
  • Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
  • Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
  • Performance status ECOG ≤3

Exclusion Criteria:

  • Prior metallic stent placement
  • Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
  • Life expectancy of less than 1 month
  • History of gastric surgery
  • Linitus plastic
  • Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
  • Coagulation disorders
  • Pregnancy
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823690


Contacts
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Contact: Anthony Y Teoh, FRCSEd 852-35052956 anthonyteoh@surgery.cuhk.edu.hk
Contact: Man Yee Yung, BSc 852-35052956 myyung@surgery.cuhk.edu.hk

Locations
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Hong Kong
Department of Surgery, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Anthony YB Teoh, FRCSEd(Gen)    85235052953    anthonyteoh@surgery.cuhk.edu.hk   
Principal Investigator: Anthony YB Teoh         
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: Anthony Teoh, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03823690    
Other Study ID Numbers: CRE-2018.335
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases