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NCT Number: NCT03223480

EUS - Guided Balloon-occluded Gastrojejunostomy Bypass

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 (DSEMS) 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 DSEMS is limited by several problems. In uncovered DSEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered DSEMS, 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 DSEMS and partially or fully covered DSEMS 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 12-16. 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. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare prospective data on EPASS versus a historical group that received DSEMS.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Surgery, Prince of Wales Hospital

Hong Kong

About this study

In recent years, DSEMSs have provided an attractive alternative to surgery for palliation of malignant gastric outlet obstruction. Several studies have assessed the clinical and technical success rates of DSEMS for malignant gastroduodenal obstruction. Technical success rates of 90% to 100% and clinical success of 80% to 95% was achieved.The procedure was associated with quicker recovery and reduced morbidities as compared to surgical gastrojejunostomies. However, the long-term patency of uncovered DSEMS is limited by the risk of tumor ingrowth that would lead to subsequent re-stenosis of the stents requiring re-intervention. Thus to palliate malignant gastric outlet obstruction, surgical gastrojejunostomy is preferred in patients that are fit for surgery with prolonged life expectancy whilst insertion of DSEMS is preferred in patients that are associated with high-risk for surgery and short life expectancy.

Recently, EUS-guided gastrojejunostomies have become possible. In the early description, a common technical problem exists in the series. The target duodenum or jejunum needed for creation of a GJ is collapsed and it is difficult to identify the target organ by EUS from the stomach. Furthermore, the insertion of the stent for creation of the anastomosis may be difficult with a collapsed bowel and this may result in catastrophic outcomes. To overcome this difficulty, our group has published the results of using the double balloon occluder that allows distension of the duodenum in conjunction with the AXIOS stent for creation of a GJ in 20 patients (Endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass - EPASS). The technical success rate was 90% (18/20). The median intubation time from the double-balloon tube intubation to stent placement was 25.5 min (range 10-39 min). Post-treatment gastric outlet obstruction scoring system (GOOSS) score improved in all 18 cases in which EPASS was successfully performed.

Thus, based on the above results, EUS-GJ may be associated with improved outcomes as compared with conventional procedures for management of malignant GOO. The aim of the current study is to compare the efficacies of EPASS in a prospective multicenter setting versus a historical cohort of uncovered DSEMS for patients suffering from unresectable malignant GOO.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive patients ≥ 18 years old
  • Biopsy and/or cytology confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
  • Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19 Performance status ECOG ≤3 (appendix 2)

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

Treatment and study plan

EUS-guided gastrojejunstomy

Device

As listed in the arms description

Primary outcomes

  1. 6 month re-intervention rate

    Time frame: 6 months

    percentage of patients requiring additional endoscopic intervention due to stent dysfunction

Secondary outcomes

  1. technical success

    Time frame: 1 day

    successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy

  2. clinical success

    Time frame: 7 days

    improvement of at least 1 point in the GOOS within 3 days after stent insertion

  3. adverse events rate

    Time frame: 30 days

    graded according to the lexicon of endoscopic adverse

  4. mortality

    Time frame: 30 days

    Death within 30 day of the procedure

  5. Post stenting gastric outlet obstruction scores

    Time frame: 7 days

    Degree of oral intake after stenting

  6. the duration of stent patency

    Time frame: 6 months

    How long the stent remains patent

  7. quality of life assessment scores

    Time frame: 6 months

    EORTC QLQ-C30

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Tokyo Medical University

Registry information

Official study title

EUS - Guided Balloon-occluded Gastrojejunostomy Bypass (EPASS) for Unresectable Malignant Gastric Outlet Obstruction.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Nov 15, 2021

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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