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Bile Reflux after Weight-Loss Surgery

Assessing bile reflux using endoscopy and HIDA scintigraphy in post-bariatric surgical patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000806268
Enrollment
81
Registered
2018-05-11
Start date
2018-07-09
Completion date
2020-07-31
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We are assessing the occurrence of bile reflux in patients who have undergone weight-loss operations. Bile reflux can predispose to oesophagitis, Barrett’s oesophagus and even oesophageal cancer. A new surgical technique has been developed and shows excellent results with regard to weight loss, remission of diabetes and safety. This technique is controversial, however, with an increased theoretical risk of bile reflux. Our study will provide additional data on the safety of weight loss operations, both generally and specifically relating to bile reflux, impacting surgical decision making in bariatric surgery. The results from our study will provide clinicians with clear evidence from which they can make informed decisions about the safety of the 'new' surgical technique. With current data showing favourable results, including improved efficacy and decreased risk of complications, increased utilisation of the technique will result in improved short-term and long-term patient outcomes. Awareness of the incidence of bile reflux post-operatively will allow clinicians to treat any reflux early, preventing or at least delaying potentially detrimental health outcomes. These interventions will translate into decreased health expenditure, providing net health and economic benefit.

Interventions

Patients planned to undergo weight-loss surgery (gastric bypass or sleeve gastrectomy) will be invited to join the study. The type of weight loss operation performed by the surgeon will not be affected by enrolment in this study. Pre-operatively, participants will undergo upper gastro-intestinal endoscopy with stomach (+/- oesophageal) biopsies and biochemical analysis of stomach fluid, blood testing and biometric measurements (weight, height, BMI, hip and waist circumference). Participants will

Patients planned to undergo weight-loss surgery (gastric bypass or sleeve gastrectomy) will be invited to join the study. The type of weight loss operation performed by the surgeon will not be affected by enrolment in this study. Pre-operatively, participants will undergo upper gastro-intestinal endoscopy with stomach (+/- oesophageal) biopsies and biochemical analysis of stomach fluid, blood testing and biometric measurements (weight, height, BMI, hip and waist circumference). Participants will also be requested to complete a symptom questionnaire. At 6 months post-operatively, participants will undergo a HIDA scan at Royal Adelaide Hospital and a repeat endoscopy with biopsies and gastric fluid samples. They will also be invited to complete again the same GERD-Q Questionnaire, in addition to an ‘Investigations Tolerability Questionnaire’. Repeat measurements of weight, height, BMI, hip and waist circumference will also be collected.

Sponsors

Discipline of Surgery, University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Obesity of >5 years duration BMI>40 or >35 plus comorbidities Documented attempts at previous weight loss Age 18-60 Good commitment to achieving weight loss Suitability for bariatric surgery

Exclusion criteria

Previously undergone obesity surgery Previously undergone gastric surgery Previously undergone gallbladder surgery Large abdominal hernias Pregnancy or are breast feeding Psychiatric illness BMI>65

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026