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

Malignant Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986890
• Other study ID #: 2022-433
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Spectrum Health Hospitals
• Contact: G. Paul Wright, MD
• Phone: 616-486-6333
• Email: paul.wright[@]corewellhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Male or female aged =18 years old.

4. 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.

5. 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.

6. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist.

Exclusion Criteria:

1. Patients that have had previous treatment for malignant gastric outlet obstruction.

a. Including any previous surgery or stent placement for MGOO

2. 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.

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• Roux-en-Y Bypass
laparoscopic Roux-en-Y
• gastrojejunostomy
surgical gastrojejunostomy

Locations

Country	Name	City	State
United States	G. Paul Wright	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days post operative
Secondary	Gastric emptying study at 30-days	Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients	30 days post operative
Secondary	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.	30 days postoperative
Secondary	Number of Clavien-Dindo grade =3 adverse event		14 days postoperative
Secondary	Number of patients requiring reoperation for any indication		30 days postoperative
Secondary	number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery		30 days postoperative
Secondary	Time from surgery to death		100 days postoperative
Secondary	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	measured pre-operatively, at 25-35 days post op and 80-100 days post op
Secondary	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	measured pre-operatively, at 25-35 days post op and 80-100 days post op