Gastric Bypass vs Gastrojejunostomy for Gastric Outlet Obstruction

Overseen By Cindy Cheung, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spectrum Health Hospitals

Disqualifiers: Previous treatment, Stent placement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgeries for malignant gastric outlet obstruction, where cancer blocks food from leaving the stomach. It compares traditional gastrojejunostomy, which connects the stomach to the small intestine, with Roux-en-Y bypass surgery, commonly used in weight loss and gastric cancer treatments. The goal is to determine which surgery enables patients to eat solid food more easily within the first 30 days post-operation. Suitable candidates have been diagnosed with this obstruction and experience symptoms like nausea, vomiting, or stomach pain due to cancer in the stomach or nearby areas. As an unphased trial, this study allows patients to contribute to research that could enhance surgical outcomes for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gastrojejunostomy is generally safe for treating blockages at the stomach's exit. In one study, 19.23% of patients experienced complications. Another study confirmed it as a safe and effective treatment for this issue.

Long-term research indicates that Roux-en-Y bypass is a well-tolerated surgery with few complications. The risk of complications is lower than for many common surgeries, such as gallbladder removal or hip replacement, suggesting that Roux-en-Y bypass is a safe choice for patients.

Both treatments have been used successfully for their specific conditions, with manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer surgical solutions for gastric outlet obstruction, a condition often managed with endoscopic stenting or limited surgical procedures. The gastrojejunostomy is a time-tested approach that directly connects the stomach to the small intestine, effectively bypassing obstructions and offering a straightforward surgical solution. On the other hand, the Roux-en-Y Bypass is a more comprehensive procedure that not only bypasses the obstruction but also prevents bile reflux, which can lead to bile gastritis. This dual approach provides options that could lead to better patient outcomes, especially for those who may not respond well to current standard treatments.

What evidence suggests that this trial's treatments could be effective for gastric outlet obstruction?

This trial will compare the effectiveness of two surgical procedures for gastric outlet obstruction: gastrojejunostomy and Roux-en-Y bypass. Studies have shown that gastrojejunostomy successfully bypasses stomach blockages in about 92.9% of cases, helping patients eat more normally. It can improve survival rates and allow further treatments for cancer-related stomach blockages. Meanwhile, research indicates that the Roux-en-Y bypass effectively aids weight loss and improves health issues like type 2 diabetes. Although primarily used in weight-loss surgery, it also effectively bypasses blockages in the stomach and the first part of the small intestine. Both procedures are well-established, but Roux-en-Y might reduce the risk of bile reflux, which can irritate the stomach. ^{4 6 7 8 9}

Who Is on the Research Team?

G. Paul Wright, MD

Principal Investigator

Corewell Health

Are You a Good Fit for This Trial?

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

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

I have a cancer-caused blockage at the stomach exit and am fit for surgery instead of stent placement.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Gastrojejunostomy
• Roux-en-Y Bypass

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Corewell Health West

Lead Sponsor

Published Research Related to This Trial

A 51-year-old woman experienced a rare complication of obstruction at the jejuno-jejunostomy just three days after undergoing Roux-en-Y gastric bypass (RYGB), highlighting the need for vigilance in monitoring post-operative patients.

The successful management of her obstruction involved urgent laparoscopic surgery, including the creation of a new jejuno-jejunostomy, demonstrating the importance of timely intervention and specialized care in addressing complications following bariatric surgery.

NCBI (Pubmed)

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. Vasas, P., Hussain, A., Owers, C., et al.[2020]

In a study of 654 patients who underwent Roux-en-Y gastric bypass, routine upper gastrointestinal (GI) series showed low sensitivity (43%) for detecting anastomotic leaks, indicating that this practice may not be reliable for identifying complications post-surgery.

The study found that a selective imaging approach, targeting patients with clinical signs of leaks or strictures, could be more effective than routine upper GI series, as the overall incidence of complications was low (0.8% for leaks and 2.4% for strictures).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine upper GI series after gastric bypass does not reliably identify anastomotic leaks or predict stricture formation. Carter, JT., Tafreshian, S., Campos, GM., et al.[2022]

Surgeons who changed their gastrojejunostomy technique from end-to-end anastomosis to linear staple or handsewn anastomosis experienced significantly lower surgical complication rates in 2021 compared to 2011, with a reduction from 5.1% to 1.9%.

Both surgeons who changed their technique and those who maintained the end-to-end anastomosis technique saw a decrease in complications, suggesting that improvements in surgical outcomes may be linked to increased experience and possibly the adoption of new technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating outcomes among surgeons who changed their technique for gastric bypass: a state-wide analysis from 2011 to 2021. Hider, AM., Johanson, H., Bonham, AJ., et al.[2023]

In a study of 92 participants who underwent Roux-en-Y gastric bypass (RYGB) surgery, those with food intolerance showed significantly poorer masticatory efficiency, with 58.3% of cases having very poor efficiency compared to 23.5% of controls.

The research found no link between food intolerance and the amount of protein or red meat consumed, suggesting that masticatory issues, rather than dietary intake, may be a key factor in food intolerance after RYGB.

NCBI (Pubmed)

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. de Almeida Godoy, CM., de Araújo Quadros Cunha, B., Furtado, MC., et al.[2021]

In a study of 197 patients who underwent laparoscopic Roux-en-Y gastric bypass, using a transverse enterotomy closure technique resulted in a 0% rate of gastrojejunostomy strictures, compared to a 16% rate with longitudinal closure, indicating a significant improvement in safety and efficacy.

The change to transverse closure also led to a reduction in surgery-related readmissions, particularly those associated with GJ strictures, highlighting the benefits of this technique in minimizing post-operative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear-stapled gastrojejunostomy with transverse hand-sewn enterotomy closure significantly reduces strictures for laparoscopic Roux-en-Y gastric bypass. Mueller, CL., Jackson, TD., Swanson, T., et al.[2021]

In a study of 457 patients undergoing laparoscopic Roux-en-Y gastric bypass, the linear-stapled gastrojejunostomy (LRYGB-LS) technique resulted in significantly longer operative times (140 minutes) compared to the circular-stapled technique (LRYGB-CS) which took 85 minutes.

Postoperative complications were lower in the LRYGB-LS group, with rates of hemorrhage (2.1% vs. 10.3%) and wound infections (1.0% vs. 9.3%) being significantly reduced compared to LRYGB-CS, indicating that while LRYGB-CS is quicker, LRYGB-LS may offer better safety in terms of these specific complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of circular- and linear-stapled gastrojejunostomy in laparoscopic Roux-en-Y gastric bypass: a multicenter study. Major, P., Janik, MR., Wysocki, M., et al.[2022]

In a randomized trial involving 77 patients who had weight regain after Roux-en-Y gastric bypass, those who underwent sutured transoral outlet reduction (TORe) experienced a significantly greater mean percentage weight loss of 3.5% compared to only 0.4% in the control group, indicating TORe's efficacy in promoting weight loss.

TORe not only helped with weight loss but also led to improvements in blood pressure and higher compliance with healthy lifestyle changes among participants, suggesting it could be a beneficial intervention for those struggling with weight management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Thompson, CC., Chand, B., Chen, YK., et al.[2018]

Laparoscopic wedge resection of gastrojejunostomy (LWGJ) is a safe procedure for patients with weight recidivism after Roux-en-Y gastric bypass (RYGB), showing no postoperative complications or readmissions in a study of 9 female patients.

One year after LWGJ, patients experienced a significant reduction in body mass index (BMI), with a mean decrease to 34.9 kg/m² and a mean percentage of excess weight loss of 64.6%, indicating its efficacy in promoting further weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Wedge Resection of Gastrojejunostomy for Weight Recidivism after Gastric Bypass. Elbahrawy, A., Bougie, A., Albader, M., et al.[2019]

In a study of 313 morbidly obese patients who underwent Roux-en-Y gastric bypass (RYGB), the length of the biliopancreatic limb (BPL) and alimentary limb (AL) did not significantly affect %excess weight loss (%EWL) after 12 months.

However, after 36 months, patients with a longer BPL experienced a significantly higher %EWL compared to those with a shorter BPL, suggesting that BPL length may play a role in long-term weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of alimentary and biliopancreatic limb length in outcomes of Roux-en-Y gastric bypass. Darabi, S., Pazouki, A., Hosseini-Baharanchi, FS., et al.[2022]

Out of 1213 patients who underwent laparoscopic Roux-en-Y gastric bypass, 10 patients (0.82%) developed perforated gastrojejunal anastomotic ulcers, typically around 13.5 months post-surgery.

Perforated GJA ulcers can be effectively managed with laparoscopic repair and an omental patch, leading to a 30% morbidity rate and a 10% mortality rate, highlighting the importance of surgical expertise in treatment.

NCBI (Pubmed)

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. Kalaiselvan, R., Exarchos, G., Hamza, N., et al.[2012]

In a study involving 10 pigs, the use of endoluminal negative pressure vacuum devices (EVD) effectively sealed gastrojejunal anastomotic leaks, with all experimental pigs showing successful closure compared to persistent leaks in control pigs.

The EVD therapy was well tolerated and demonstrated significant efficacy in healing leaks, suggesting it could be a promising treatment for complications following Roux-en-Y gastric bypass surgery in humans.

NCBI (Pubmed)

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. Scott, RB., Ritter, LA., Shada, AL., et al.[2018]

A study involving 848 patients undergoing Roux-en-Y gastric bypass (RYGB) surgery found that genetic factors significantly influence weight loss outcomes, with first-degree relatives showing a similar response to surgery (9% mean difference in excess weight loss).

In contrast, unrelated cohabitating individuals and randomly paired individuals exhibited much larger differences in weight loss (26% and 25% mean differences, respectively), indicating that genetic similarity plays a crucial role in predicting the effectiveness of RYGB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heritability of the weight loss response to gastric bypass surgery. Hatoum, IJ., Greenawalt, DM., Cotsapas, C., et al.[2021]

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