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Endoscopic Management of Weight Regain post Gastric Bypass

Argon Plasma Coagulation and Endoscopic Suturing in the management of weight regain after gastric bypass surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000624189
Acronym
Not applicable
Enrollment
60
Registered
2019-04-26
Start date
2019-05-06
Completion date
2020-03-09
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

Dilated Gastrojejunal stoma can lead to weight regain after gastric bypass surgery. Endoscopic revision with endoluminal suturing or argon plasma coagulation is currently performed as a first line treatment in the United States, given that surgical revision is associated with significant risk of complications. Studies have demonstrated that endoscopic intervention is effective, safe and most patients avoided surgery. In this study, we aim to describe our experience in endoscopic techniques used to treat weight regain after gastric bypass surgery. Our overall objective is to assess the long-term outcome of endoscopic intervention at a tertiary referral centre.

Interventions

Endoscopic revision of a dilated gastrojejunal (GJ) stoma using endoluminal suturing or argon plasma coagulation (APC) 1) Endoluminal suturing involves the placement of sutures at the GJ stoma using a suturing platform that fixed on the end of a flexible endoscope, resulting in reduction of the lumen size 2. APC involves the use of a jet of ionized argon gas (plasma) that is directed through a catheter placed down the working channel of an endoscope. The probe is placed near the mucosa, and ar

Endoscopic revision of a dilated gastrojejunal (GJ) stoma using endoluminal suturing or argon plasma coagulation (APC) 1) Endoluminal suturing involves the placement of sutures at the GJ stoma using a suturing platform that fixed on the end of a flexible endoscope, resulting in reduction of the lumen size 2. APC involves the use of a jet of ionized argon gas (plasma) that is directed through a catheter placed down the working channel of an endoscope. The probe is placed near the mucosa, and argon gas is emitted then ionized by a high voltage discharge resulting in controlled thermal injury to the stoma. Subsequent healing with fibrosis leads to narrowing of the GJ stoma. This is a single-centre study (Endoscopy Unit, Gastroenterology and Hepatology Department, The Royal Brisbane and Women's Hospital, Queensland). All procedures will be performed by 1 of 2 experienced endoscopists (Dr Patrick Walsh or Dr Jason Huang). Participants undergoing the procedure will require either a general anesthetic or propofol based sedation depending on patient factors, as per standard practice. Eligible participants will be identified from the bariatric clinic and consented. The gastroscopy (Olympus, Japan), overstitch device (Apollo Endosurgery, USA), APC system (ERBE, Germany) and biopsy forceps (Boston, USA) will be utilized. Selecting therapy for participants based on the size of the GJ stoma: A gastroscopy will be performed to allow initial inspection and measurement of the size of the GJ stoma using a jumbo biopsy forceps, with an 8mm opening. The opened biopsy forceps will be placed at the lumen of the GJ stoma, allowing direct measurement of the size. Participants with a stoma size of less than 15mm will be treated with APC, while other participants (i.e.: stoma size more than or equal to 15mm) will be treated with the overstitch device. Participants will be routinely admitted into the ward for observation and discharge the following day. They are on small volume of clear fluids liquid on the day of the procedure. On discharge, the participants are placed on 2 weeks of very low energy diet meal replacements shakes. They will progress onto fluid diet and soft diet and gradually return to a normal diet over 8 weeks under the supervision of the dietitian in the bariatric clinic. Participants will then be reviewed in the bariatric clinic together with a dietitian at 3-, 6-, 9-, 12-, 18-, and 24- months. Follow up weight change, body mass index (BMI), percentage EWL and percentage of total weight loss will be measured in these clinic consultations. All participants will have a repeat endoscopy at 3 months to measure post intervention stoma size.

Sponsors

Department of Gastroenterology and Hepatology, The Royal Brisbane and Women's Hospital, Queensland
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: • Minimal post-operative period of 18 months; • Regain of at least 10% of lowest weight attained post RYGB • Anastomotic diameter of at least 12mm • Able to provide consent for the procedure

Exclusion criteria

• Inability to give informed consent • Women who are pregnant or intending to become pregnant in the 12 months after procedure • Advanced medical comorbidities defined as o Decompensated cirrhosis o Cardiac failure with NYHA class III and IV symptoms o COPD – Stage III and IV o Kidney dysfunction on dialysis o Active cancer undergoing treatment o Cerebrovascular accident causing significant functional impairment o Severe nutritional deficiencies o alcoholism o drug addiction o recent neoplasia (less than 5 years) o HIV seropositivity • Anti-coagulant or anti-platelet agent, with the exception of Aspirin • Allergy to medications used for anaesthetics

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026