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Effect of Transoral Outlet Reduction on Hepatic Fibrosis in Roux-en-Y Gastric Bypass Patients with Weight Regain and Non-alcoholic Fatty Liver Disease

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Abstract

Purpose

Weight regain after Roux-en-Y gastric bypass (RYGB) is associated with worsening of liver outcomes. However, the effect of transoral outlet reduction (TORe) on liver fibrosis in RYGB patients with weight regain and possible advanced fibrosis remains unknown.

Materials and Methods

This was a retrospective analysis of prospectively collected data of RYGB patients who underwent TORe for weight regain. Only patients with possible advanced fibrosis were included. TORe was performed using either an endoscopic suturing device (S-TORe) or plication device (P-TORe) to reduce the gastrojejunal anastomosis (GJA) and pouch sizes. Primary outcomes included changes in non-invasive tests (NITs) for fibrosis at 6–12 months. Secondary outcomes included weight loss and changes in insulin resistance and lipid profile at 6–12 months.

Results

Fifty RYGB patients were included. Baseline age and BMI were 55 ± 11 years and 40.1 ± 7.3 kg/m2. Baseline GJA and pouch sizes were 20 ± 7 mm and 5 ± 2 cm, respectively. Thirty patients (60%) underwent S-TORe and 20 patients (40%) underwent P-TORe. At 12 months following TORe, there were statistically significant improvements in NITs for fibrosis, including ALT, AST and FIB-4. There was a trend towards significant improvement in liver stiffness measurement on transient elastography. Patients experienced 8.8 ± 11.2% total weight loss (TWL) (p < 0.0001), with 60% experiencing at least 10% TWL. Additionally, there was a significant improvement in HbA1c and a trend toward significant improvement in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), suggestive of improved insulin sensitivity.

Conclusion

TORe is associated with an improvement in hepatic fibrosis in patients with NAFLD and possible advanced fibrosis.

Graphical Abstract

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Data Availability

Informed consent is not applicable in this study.

Abbreviations

TORe:

Transoral Outlet Reduction

RYGB:

Roux-en-Y Gastric Bypass

NAFLD:

Nonalcoholic Fatty Liver Disease

EBMTs:

Endoscopic Bariatric and Metabolic Therapies

S-TORe:

Transoral Outlet Reduction using Endoscopic Suturing Device

P-TORe:

Transoral Outlet Reduction using Plication Device

NITs:

Non-invasive tests

GJA:

Gastrojejunal anastomosis

TWL:

Total weight loss

HSI:

Hepatic Steatosis Index

FIB-4:

Fibrosis-4 Index

APRI:

Aspartate aminotransferase to platelet ratio

LSM:

Liver Stiffness Measurement

IOP:

Incisionless Operating Platform

APC:

Argon plasma coagulation

ESD:

Endoscopic Submucosal Dissection

PPI:

Proton Pump Inhibitor

AST:

Aspartate aminotransferase

ALT:

Alanine aminotransferase

VCTE:

Vibration-controlled transient elastography

HbA1c:

Hemoglobin A1c

HOMA-IR:

Homeostatic Model Assessment for Insulin Resistance

AEs:

Adverse Events

ASGE:

American Society Gastrointestinal Endoscopy

SD:

Standard Deviation

BMI:

Body Mass Index

NFS:

NAFLD Fibrosis Score

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Authors and Affiliations

  1. Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, USA

    Aunchalee Jaroenlapnopparat, Christopher C. Thompson & Pichamol Jirapinyo

  2. Department of Medicine, Mount Auburn Hospital/Beth Israel Lahey Health, Cambridge, MA, 02138, USA

    Aunchalee Jaroenlapnopparat

  3. Harvard Medical School, Boston, MA, 02115, USA

    Christopher C. Thompson & Pichamol Jirapinyo

Authors
  1. Aunchalee Jaroenlapnopparat
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  3. Pichamol Jirapinyo
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Contributions

A.J.: Data collection, statistical analysis, manuscript preparation.

C.T.: Patient recruitment, performing procedures and follow-ups and critical review of the manuscript.

P.J.: Study design and concept, patient recruitment, performing procedures and follow-ups, data collection, statistical analysis, manuscript preparation, critical review of the manuscript.

Corresponding author

Correspondence to Pichamol Jirapinyo.

Ethics declarations

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Human and Animal Rights

For this type of study formal consent is not required.

Conflict of Interests

A.J. has no conflict of interest. C.T. has served as a consultant for Apollo Endosurgery, Boston Scientific, Enterasense, EnVision Endoscopy, Fractyl, USGI Medical, Medtronic/Covidien, Olympus/Spiration and GI Dynamics, has served as an advisory boards member for USGI Medical and Fractyl, has received research grant and support from USGI Medical, Apollo Endosurgery, Boston Scientific, ERBE, FujiFilm, Lumendi Olympus/Spiration, Aspire Bariatrics and GI Dynamics, has served as a general partners for Blueframe Healthcare, has served as a founder for Enterasense, EnVision Endoscopy and GI Windows, and holds stock and royalties for GI Windows. P.J. has received research support from Apollo Endosurgery, Boston Scientific, Fractyl, GI Dynamics and USGI Medical, has served as a consultant to Apollo Endosurgery, ERBE, GI Dynamics and Spatz Medical and has received royalty from Endosim.

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Key Points

- Weight regain following RYGB is associated with worsening NAFLD.

- Transoral outlet reduction (TORe) is associated with not only clinically significant weight loss but also improvement in hepatic fibrosis in patients with NAFLD and possible advanced fibrosis.

- There was a trend towards the improvement of insulin sensitivity after TORe.

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Jaroenlapnopparat, A., Thompson, C.C. & Jirapinyo, P. Effect of Transoral Outlet Reduction on Hepatic Fibrosis in Roux-en-Y Gastric Bypass Patients with Weight Regain and Non-alcoholic Fatty Liver Disease. OBES SURG 33, 2303–2310 (2023). https://doi.org/10.1007/s11695-023-06668-2

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