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Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction

Primary Purpose

Malignant Gastric Outlet Obstruction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EUS-guided gastroenterostomy (EUS-GE)
Laparoscopic gastroenterostomy (LGE)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Gastric Outlet Obstruction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Consecutive patients ≥ 20 years old
  2. Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
  3. Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
  4. Performance status ECOG ≤3

Exclusion Criteria:

  1. Unable to give informed consent
  2. Prior duodenal metallic stent placement
  3. Severe comorbidities precluding the endoscopic procedure or operation
  4. Life expectancy of less than 1 month
  5. History of gastric surgery
  6. Linitus plastic
  7. Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
  8. Coagulation disorders
  9. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    EUS-guided gastroenterostomy (EUS-GE)

    Laparoscopic gastroenterostomy (LGE)

    Arm Description

    All EUS-GE procedures were performed under general anesthesia with endotracheal intubation. A forward-viewing gastroscope or side-viewing duodenoscope is first inserted into the site of the obstruction and a 0.025- or 0.035-inch stiff GW is placed down-stream of the jejunum beyond the obstruction as far as possible. Then, oral enteral tube is placed where the jejunum intended for stent placement under fluoroscopic guidance. After exchanging to EUS endoscope, the target jejunum is visualized by EUS after continuously injection of mixed saline and contrast medium. Finally, the gastrojejunostomy stent is directly advanced from the gastric wall into the target jejunum by AXIOS-EC delivery system.

    All LGE were performed in the operation room with patients under general anesthesia. After CO2 insufflation, 4 to 5 trocars were introduced. Next, the Treitz ligament was identified. An anterior, dorsal laterolateral, or side- to-side isoperistaltic gastroenteric anastomosis was constructed. The exact location of the gastroenteric anastomosis, with regard to the Treitz ligament, varied from 30 to 60 cm.

    Outcomes

    Primary Outcome Measures

    Time to functional recovery (days)
    Functional recovery is reached when all of the following criteria are met: 1) adequate pain control with oral analgesia only, 2) restoration of mobility to an independent level (or to preoperative level if previously impaired, 3) ability to maintain sufficient caloric intake (minimum of 50% required calories), 4) absence of intravenous fluid administration, and 5) no signs of active abdominal infection.

    Secondary Outcome Measures

    Technical success rate
    The successful gastroenterostomy was confirmed by endoscopy or operation
    Clinical success rate
    Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within one week after gastroenterostomy
    Re-intervention rate
    The percentage of patients requiring additional endoscopic intervention due to stent dysfunction
    Duration of gastroenterostomy patency
    Calculated from the time of gastroenterostomy creation to the time of gastroenterostomy dysfunction
    Adverse events rates
    Graded according to the lexicon of endoscopic adverse events
    Gastric outlet obstruction scores (GOOS)
    Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet
    Quality of life assessment scores
    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.
    Quality of life assessment scores
    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.

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    September 29, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05564143
    Brief Title
    Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction
    Official Title
    Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction: A Multi-centered Prospective Randomized Controlled Trial (ENCOURAGE Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Gastric outlet obstruction (GOO), defined by a mechanical obstruction of the duodenum, pylorus, or antrum, may result from various diseases. GOO was caused by underlying malignancy in up to 85% of patients, most of which could be attributed to pancreatic cancer. Malignant GOO may increase morbidity, reducing quality of life, and significantly influencing tolerability and efficacy of oncologic treatments. Before the advent of EUS-guided gastroenterostomy (EUS-GE), placement of enteral self-expandable metallic stents (SEMS) or surgical gastroenterostomy (SGE) are the standard of care for many years. The main shortcoming of enteral SEMS placement is recurrent GOO due to tumor ingrowth/overgrowth, which occurs in the majority of patients who survive longer than 6 months. On the other hand, the main limitation of SGE is its invasive nature, especially in such patients with advanced malignancies and poor nutritional status. In addition, SGE is associated with frequent complications, such as perioperative infections and gastroparesis. EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant GOO. Several systematic reviews and meta-analysis demonstrated the feasibility, efficacy and safety of EUS-GE. Compared with laparoscopic GE (LGE), EUS-GE not only had almost identical technical and clinical success but also reduced time to oral intake, shorter median hospital stay, and lower rate of adverse events. However, data directly comparing EUS-GE to LGE are limited. We aimed to compare clinical outcomes between EUS-GE and LGE in the palliation of malignant GOO under a randomized setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Gastric Outlet Obstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EUS-guided gastroenterostomy (EUS-GE)
    Arm Type
    Active Comparator
    Arm Description
    All EUS-GE procedures were performed under general anesthesia with endotracheal intubation. A forward-viewing gastroscope or side-viewing duodenoscope is first inserted into the site of the obstruction and a 0.025- or 0.035-inch stiff GW is placed down-stream of the jejunum beyond the obstruction as far as possible. Then, oral enteral tube is placed where the jejunum intended for stent placement under fluoroscopic guidance. After exchanging to EUS endoscope, the target jejunum is visualized by EUS after continuously injection of mixed saline and contrast medium. Finally, the gastrojejunostomy stent is directly advanced from the gastric wall into the target jejunum by AXIOS-EC delivery system.
    Arm Title
    Laparoscopic gastroenterostomy (LGE)
    Arm Type
    Active Comparator
    Arm Description
    All LGE were performed in the operation room with patients under general anesthesia. After CO2 insufflation, 4 to 5 trocars were introduced. Next, the Treitz ligament was identified. An anterior, dorsal laterolateral, or side- to-side isoperistaltic gastroenteric anastomosis was constructed. The exact location of the gastroenteric anastomosis, with regard to the Treitz ligament, varied from 30 to 60 cm.
    Intervention Type
    Procedure
    Intervention Name(s)
    EUS-guided gastroenterostomy (EUS-GE)
    Intervention Description
    Treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic gastroenterostomy (LGE)
    Intervention Description
    Treatment
    Primary Outcome Measure Information:
    Title
    Time to functional recovery (days)
    Description
    Functional recovery is reached when all of the following criteria are met: 1) adequate pain control with oral analgesia only, 2) restoration of mobility to an independent level (or to preoperative level if previously impaired, 3) ability to maintain sufficient caloric intake (minimum of 50% required calories), 4) absence of intravenous fluid administration, and 5) no signs of active abdominal infection.
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Technical success rate
    Description
    The successful gastroenterostomy was confirmed by endoscopy or operation
    Time Frame
    1 day
    Title
    Clinical success rate
    Description
    Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within one week after gastroenterostomy
    Time Frame
    1 week
    Title
    Re-intervention rate
    Description
    The percentage of patients requiring additional endoscopic intervention due to stent dysfunction
    Time Frame
    6 months
    Title
    Duration of gastroenterostomy patency
    Description
    Calculated from the time of gastroenterostomy creation to the time of gastroenterostomy dysfunction
    Time Frame
    6 months
    Title
    Adverse events rates
    Description
    Graded according to the lexicon of endoscopic adverse events
    Time Frame
    6 months
    Title
    Gastric outlet obstruction scores (GOOS)
    Description
    Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet
    Time Frame
    6 months
    Title
    Quality of life assessment scores
    Description
    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.
    Time Frame
    6 months
    Title
    Quality of life assessment scores
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consecutive patients ≥ 20 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: Unable to give informed consent Prior duodenal metallic stent placement Severe comorbidities precluding the endoscopic procedure or operation 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Ting Kuo, MD, MSc
    Phone
    +886-223123456
    Ext
    265587
    Email
    sfstruck@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make IPD available

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    Endoscopic Ultrasound-guided Versus Surgical Gastroenterostomy for Malignant Gastric Outlet Obstruction

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