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Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

Primary Purpose

Malignant Gastric Outlet Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roux-en-Y Bypass
gastrojejunostomy
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Gastric Outlet Obstruction focused on measuring MGOO, Malignant gastric outlet obstruction, gastric outlet, malignant tumor, proximal bowel obstruction, bowel obstruction

Eligibility Criteria

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

Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged ≥18 years old. Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as malignant cancer growth of any organ origin in the area of the distal stomach or duodenum preventing normal gastric emptying as determined by symptoms and cross-sectional imaging studies. ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting. iii. Cross sectional imaging findings can include tumor growth in the area of the distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed bowel distal to obstruction point. Patients deemed to benefit from surgical bypass as opposed to stent placement, by the primary surgeon. This includes assessing participants survival chances and ability to undergo a surgical procedure. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist. Exclusion Criteria: Patients that have had previous treatment for malignant gastric outlet obstruction. a. Including any previous surgery or stent placement for MGOO Patients with MGOO deemed to benefit more from endoscopic stent placement rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.

Sites / Locations

  • G. Paul WrightRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Roux-en-Y Bypass

Gastrojejunostomy

Arm Description

laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.

surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.

Outcomes

Primary Outcome Measures

Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients

Secondary Outcome Measures

Gastric emptying study at 30-days
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Patient reported daily gastric outlet obstruction scoring system (GOOS) score
Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.
Number of Clavien-Dindo grade ≥3 adverse event
Number of patients requiring reoperation for any indication
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
Time from surgery to death
Improvement of quality of life as measured by short form QOL Questionnaire
The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Improvement of quality of life as measured GIQLI
The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life

Full Information

First Posted
August 3, 2023
Last Updated
September 26, 2023
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05986890
Brief Title
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Official Title
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is intended to investigate whether roux-en-y bypass surgery is superior to conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with improved solid food intake in the first 30 days after surgery.
Detailed Description
Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea and vomiting. Most often, this signifies advanced neoplastic disease with associated poor prognosis for patients. Restoring patients to oral intake is important for palliative purposes. The current standard of care in patients requiring long-term alleviation of symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an intestinal bypass to the site of obstruction in the duodenum or distal stomach. This procedure has long been criticized for its poor resultant function for patients, mainly due to poor tolerance to food intake that include frequent episodes of nausea and vomiting and inability to for solid food intake. The need for a durable solution to malignant gastric outlet obstruction that provides better tolerance to solid food intake is evident. The roux-en-y gastric bypass procedure has been performed for a variety of indications for decades, most commonly for weight loss but also with oncologic resections of the stomach in cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the standard for this procedure in experienced hands and has been found to be safe in the short- and long term. The long-term function after R-Y bypass is generally favorable across published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric bypass in patients with malignant gastric outlet obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Gastric Outlet Obstruction
Keywords
MGOO, Malignant gastric outlet obstruction, gastric outlet, malignant tumor, proximal bowel obstruction, bowel obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roux-en-Y Bypass
Arm Type
Other
Arm Description
laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.
Arm Title
Gastrojejunostomy
Arm Type
Other
Arm Description
surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y Bypass
Intervention Description
laparoscopic Roux-en-Y
Intervention Type
Procedure
Intervention Name(s)
gastrojejunostomy
Intervention Description
surgical gastrojejunostomy
Primary Outcome Measure Information:
Title
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
Description
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Time Frame
7 days post operative
Secondary Outcome Measure Information:
Title
Gastric emptying study at 30-days
Description
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Time Frame
30 days post operative
Title
Patient reported daily gastric outlet obstruction scoring system (GOOS) score
Description
Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.
Time Frame
30 days postoperative
Title
Number of Clavien-Dindo grade ≥3 adverse event
Time Frame
14 days postoperative
Title
Number of patients requiring reoperation for any indication
Time Frame
30 days postoperative
Title
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
Time Frame
30 days postoperative
Title
Time from surgery to death
Time Frame
100 days postoperative
Title
Improvement of quality of life as measured by short form QOL Questionnaire
Description
The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Time Frame
measured pre-operatively, at 25-35 days post op and 80-100 days post op
Title
Improvement of quality of life as measured GIQLI
Description
The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Time Frame
measured pre-operatively, at 25-35 days post op and 80-100 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged ≥18 years old. Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as malignant cancer growth of any organ origin in the area of the distal stomach or duodenum preventing normal gastric emptying as determined by symptoms and cross-sectional imaging studies. ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting. iii. Cross sectional imaging findings can include tumor growth in the area of the distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed bowel distal to obstruction point. Patients deemed to benefit from surgical bypass as opposed to stent placement, by the primary surgeon. This includes assessing participants survival chances and ability to undergo a surgical procedure. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist. Exclusion Criteria: Patients that have had previous treatment for malignant gastric outlet obstruction. a. Including any previous surgery or stent placement for MGOO Patients with MGOO deemed to benefit more from endoscopic stent placement rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
G. Paul Wright, MD
Phone
616-486-6333
Email
paul.wright@corewellhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Peariso, MSN
Phone
6164860358
Email
esther.peariso@corewellhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Paul Wright, MD
Organizational Affiliation
Corewell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. Paul Wright
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. Paul M Wright, MD
Phone
616-486-6333
Email
paul.wright@corewellhealth.org
First Name & Middle Initial & Last Name & Degree
Esther L Peariso, MSN
Phone
616-486-0358
Email
esther.peariso@corewellhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
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Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

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