Gastric Bypass vs Gastrojejunostomy for Gastric Outlet Obstruction

Overseen By Esther Peariso, MSN

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

Trial Summary

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}

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.

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

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

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
• 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.

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

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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

Laparoscopic Wedge Resection of Gastrojejunostomy for Weight Recidivism after Gastric Bypass. [2019]

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]

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

Heritability of the weight loss response to gastric bypass surgery. [2021]

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]

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

The role of alimentary and biliopancreatic limb length in outcomes of Roux-en-Y gastric bypass. [2022]

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]

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]

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]

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]

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]