Gastric Bypass vs Gastrojejunostomy for Gastric Outlet Obstruction

Recruiting in Palo Alto (17 mi)

Overseen by G. Paul Wright, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Spectrum Health Hospitals

Disqualifiers: Previous treatment, Stent placement, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Gastrojejunostomy, Loop Gastrojejunostomy, Gastrojejunostomy, Roux-en-Y Bypass, Roux-en-Y Gastric Bypass, RYGB, Gastric Bypass Surgery for gastric outlet obstruction?

Roux-en-Y gastric bypass (RYGB) is known for its effectiveness in achieving sustainable weight loss in individuals with severe obesity, which suggests its potential effectiveness in treating gastric outlet obstruction by altering the stomach's structure and function. ^{1 2 3 4 5}

Is Roux-en-Y gastric bypass generally safe for humans?

Roux-en-Y gastric bypass (RYGB) is considered a safe and commonly performed surgery for weight loss, but it can have complications like bleeding, leaks, and food intolerance. ^{4 6 7 8 9}

How is the Roux-en-Y gastric bypass treatment different from other treatments for gastric outlet obstruction?

Roux-en-Y gastric bypass (RYGB) is unique because it involves creating a small stomach pouch and connecting it directly to the small intestine, bypassing a large part of the stomach and duodenum, which can help reduce complications like strictures and ulcers compared to other treatments. This approach is well-established for weight loss in obesity, but its application for gastric outlet obstruction is less common, making it a novel option for this condition. ^{2 8 10 11 12}

Research Team

G. Paul Wright, MD

Principal Investigator

Corewell Health

Eligibility Criteria

This trial is for adults (≥18 years) with malignant gastric outlet obstruction, which causes symptoms like abdominal pain and vomiting. Participants must be able to undergo surgery under general anesthesia and have not had previous treatments for this condition. They should consent to study procedures and be available throughout the study.

Inclusion Criteria

Provision of signed and dated informed consent form

I am 18 years old or older.

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

Exclusion Criteria

My doctor recommends a stent over surgery for my gastric outlet obstruction.

I have had treatment for a blockage in my stomach caused by cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either Roux-en-Y gastric bypass or loop gastrojejunostomy surgery

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for gastric emptying and quality of life improvements

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for long-term safety and effectiveness after surgery

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Gastrojejunostomy (Procedure)
• Roux-en-Y Bypass (Procedure)

Trial Overview The study compares two surgeries: Roux-en-Y Gastric Bypass versus Loop Gastrojejunostomy, to see which one is better at improving solid food intake within the first month after surgery in patients with malignant gastric outlet obstruction.

Participant Groups

Group I: Roux-en-Y Bypass Experimental Treatment 1 Intervention

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.

Group II: Gastrojejunostomy Experimental Treatment 1 Intervention

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.

Gastrojejunostomy is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Gastrojejunostomy for:

• Malignant gastric outlet obstruction
• Obstruction due to peptic ulcer disease
• Other benign obstructions

🇪🇺 Approved in European Union as Gastrojejunostomy for:

• Malignant gastric outlet obstruction
• Benign gastric outlet obstruction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

G. Paul Wright Grand Rapids, MI

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Patients Recruited

553,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. [2018] Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe).

2. Germany pubmed.ncbi.nlm.nih.gov

Endoluminal vacuum therapy for gastrojejunal anastomotic leaks after Roux-en-Y gastric bypass: a pilot study in a swine model. [2018] Roux-en-Y gastric bypass (RYGB) consistently produces the most sustainable weight loss among common interventions for morbid obesity. Anastomotic leaks at the gastrojejunal (GJ) connection result in severe morbidity. We apply endoluminal negative pressure vacuum devices (EVD) to heal anastomotic leaks in a swine model.

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Wedge Resection of Gastrojejunostomy for Weight Recidivism after Gastric Bypass. [2019] Weight recidivism after Roux-en-Y gastric bypass (RYGB) is a common problem. Often, this weight loss failure or regain may be due to a wide gastrojejunostomy (GJ). We evaluated the feasibility and safety of a novel approach of laparoscopic wedge resection of gastrojejunostomy (LWGJ) for a wide stoma after RYGB associated with weight recidivism.

4. United States pubmed.ncbi.nlm.nih.gov

What Every Bariatric Surgeon Should Know: How to Relieve Obstruction at the Jejuno-jejunostomy After Roux-en-Y Gastric Bypass. [2020] Roux-en-Y gastric bypass (RYGB) remains one of the key bariatric procedures worldwide. In addition to bleeding and anastomotic leak, there are rarely occurring complications such as obstruction at the jejuno-jejunostomy in the early postoperative phase.

5. United States pubmed.ncbi.nlm.nih.gov

Heritability of the weight loss response to gastric bypass surgery. [2021] The use of Roux-en-Y gastric bypass (RYGB) surgery to treat severe obesity has grown dramatically. RYGB is highly effective, but the response in individual patients varies widely, and clinical predictors have been able to explain only a fraction of this variation.

6. Germany pubmed.ncbi.nlm.nih.gov

Routine upper GI series after gastric bypass does not reliably identify anastomotic leaks or predict stricture formation. [2022] Many surgeons who perform Roux-en-Y gastric bypass (RYGB) for morbid obesity routinely obtain an upper gastrointestinal (GI) series in the early postoperative period to search for anastomotic leaks and signs of stricture formation at the gastrojejunostomy. We hypothesized that this practice is unreliable.

7. Poland pubmed.ncbi.nlm.nih.gov

The role of alimentary and biliopancreatic limb length in outcomes of Roux-en-Y gastric bypass. [2022] Roux-en-Y gastric bypass (RYGB) is one of the safe and easily reproducible bariatric procedures.

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluating outcomes among surgeons who changed their technique for gastric bypass: a state-wide analysis from 2011 to 2021. [2023] Technical variation exists when performing the gastrojejunostomy during Roux-en-Y gastric bypass (RYGB). However, it is unclear whether changing technique results in improved outcomes or patient harm.

9. United States pubmed.ncbi.nlm.nih.gov

Relationship of Food Intolerance 2 Years After Roux-en-Y Gastric Bypass Surgery for Obesity with Masticatory Efficiency and Protein Consumption. [2021] Roux-en-Y gastric bypass (RYGB) is among the most performed bariatric surgery techniques. One known complication of RYGB surgery is food intolerance, which may limit the intake of protein.

10. United States pubmed.ncbi.nlm.nih.gov

Incidence of perforated gastrojejunal anastomotic ulcers after laparoscopic gastric bypass for morbid obesity and role of laparoscopy in their management. [2012] Laparoscopic Roux-en-Y gastric bypass (RYGB) is a well-established procedure to treat morbid obesity. Gastrojejunal anastomotic (GJA) ulcers can develop after surgery with subsequent perforation. Our aim was to evaluate the incidence, presentation and outcome of management of perforated GJA ulcer disease after laparoscopic RYGB.

11. United States pubmed.ncbi.nlm.nih.gov

Linear-stapled gastrojejunostomy with transverse hand-sewn enterotomy closure significantly reduces strictures for laparoscopic Roux-en-Y gastric bypass. [2021] Gastrojejunostomy (GJ) stricture is a common complication after Roux-en-Y gastric bypass (RYGB) for morbid obesity, and the optimal anastomotic technique remains uncertain. The objective of this study was to use cumulative summation (CUSUM) analysis to compare rates of gastrojejunostomy strictures after linear stapling with longitudinal versus transverse enterotomy closure in gastric bypass patients.

12. Poland pubmed.ncbi.nlm.nih.gov

Comparison of circular- and linear-stapled gastrojejunostomy in laparoscopic Roux-en-Y gastric bypass: a multicenter study. [2022] Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a common, well-established procedure, but no consensus regarding selection of the gastrojejunostomy (GJ) technique has been reached, and standardization of this precise technique is far from being achieved.