Endoscopic Sleeve Gastroplasty in the
Armamentarium of Bariatric Treatment in Thailand: A TAGE-TSMBS Joint Addendum Statement to TSMBS Consensus Guideline
*Thai Association of Gastrointestinal Endoscopy, **Thai Bariatric surgery Society of Metabolic and Bariatric Surgery, Thailand
ABSTRACT
The Thai bariatric surgery Society of Metabolic and Bariatric Surgery (TSMBS) has recently published a consensus guideline for the treatment of obesity, which has become an emerging health crisis in Thailand. As endoscopic sleeve gastroplasty (ESG) lately became available in the country, the TSMBS and the Thai Association for Gastrointestinal Endoscopy (TAGE) then agreed to propose this addendum statement that aims to standardize the patient selection protocol, physician credentialing, and procedural data monitoring in order to safely and effectively incorporate ESG into the armamentarium of bariatric treatment of Thailand.
289-292)
INTRODUCTION
Over the past decade, the prevalence of obesity has been rising at an alarming rate and has now become an emerging health crisis in Thailand.1-3 Obesity is recognized as an epidemic of a chronic, relapsing, and debilitating disease that poses significant health consequences in addition to an enormous economic burden to our healthcare system.1,4,5 Recently, the Thai bariatric surgery Society of Metabolic and Bariatric Surgery (TSMBS) has published a consensus guideline for the treatment of obese patients.6 The guideline has standardized bariatric surgery protocol in Thailand, stating that the indication for bariatric surgery includes patients with BMI between
32.5-37.5 kg/m² with co-morbidities and those whose
BMI of more than 37.5 kg/m² without co-morbidities.6
The efficacy of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy for weight reduction is well-established, and they currently remain the standard of care in the Thai population.6,7 However, the current guideline did not include patients whose BMI are less than 37.5 kg/m² without co-morbidities as candidates for primary surgical intervention,4,6 underscoring a therapeutic gap for which an alternate treatment modality can be offered.3
Endoscopic sleeve gastroplasty (ESG) is one of the bariatric endoscopy techniques that offers a less invasive approach that is safe, effective, repeatable, and reversible.8-11 In addition, ESG has been shown to improve
Corresponding author: Sutdhachit Linananda
E-mail: sutdhacit.li@thaindc.org
Received 29 January 2021 Revised 2 April 2021 Accepted 2 April 2021
ORCID ID: http://orcid.org/0000-0003-4267-0996 http://dx.doi.org/10.33192/Smj.2021.38
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
Volume 73, No.5: 2021 Siriraj Medical Journal 289
Kongkam et al.
obesity-related comorbidities, including diabetes and hypertension.12-14 The procedure entails an incisionless longitudinal full-thickness plication along the greater curvature of stomach using an overstitch device. ESG has been adopted and widely accepted as an effective endoscopic bariatric therapy according to the American Society for Gastrointestinal Endoscopy (ASGE)/ the American Society for Metabolic and Bariatric Surgery (ASMBS) thresholds of >25% excessive weight loss and
<5% adverse events.9-11,15,16
As the endoscopic suturing device has recently become available in Thailand, ESG is expected to soon emerge as one of the bariatric therapies being offered to patients with morbid obesity. However, the current TSMBS guideline was developed when ESG was not an available option and focused only on bariatric surgical therapies, pre-operative and post-operative management, which were in a different context compared to the endoscopic counterpart in its early phase. For example, there is no specialized formal training program on ESG in the country yet, together with limited hands-on proctorship from international colleagues due to the COVID-19 pandemic, all expert endoscopists were trained virtually. In addition, although the role of ESG is established in the international communities but there is no currently available local data on ESG to formulate a national high-level evidence guidelines yet. Thai Association
of Gastrointestinal Endoscopy (TAGE) and TSMBS recognized the importance of standardizing the patient selection protocol, training process, competency evaluation, and safety data monitoring to incorporate ESG into the armamentarium of bariatric treatment of Thailand. This joint addendum statement therefore aims to address the aforementioned issues and provide a pathway to safely and effectively bring ESG into clinical practice and improve care for our patients in an early era of ESG procedure in Thailand.
MATERIALS AND METHODS
This addendum statement was conceptualized and created using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) and the Strength of Recommendation Taxonomy (SORT) framework17,18 as described in Table 1.
Nominated experts from both societies convened in January 2021 in Bangkok, Thailand to discuss 4 aspects of bariatric schematic management; 1) Pre-procedural evaluation, 2) Procedural indications and patient selection,
3) Physician training and credentialing, 4) Post-procedure monitoring based on a literature review utilizing Medline, Cochrane library, and Embase databases for existing evidence. The recommendations were approved when the consensus of all experts was reached for each aspect. The summary of
TABLE 1. Classification of the quality of evidence and strength of recommendations.
Quality of evidence
A (strong) Strongly confident in the effect of estimate.
B (moderate) Moderately confident in the effect of estimate. C (weak) Confidence in the effect of estimate is limited.
D (very weak) Almost no confidence in the effect of estimate.
Strength of the recommendation
Level 1 Recommendation based on consistent and good-quality patient-oriented
evidence.
Level 2 Recommendation based on inconsistent or limited-quality patient-oriented
evidence.
Level 3 Recommendation based on consensus, usual practice, opinion,
disease-oriented evidence, or case series for studies of diagnosis,
treatment, prevention, or screening studies
290 Volume 73, No.5: 2021 Siriraj Medical Journal https://he02.tci-thaijo.org/index.php/sirirajmedj/index
1. The patient should be evaluated in a multi-disciplinary team approach focusing on behavioral eating habit, endocrinopathies, and other obesity-related co- morbidities. (Quality of evidence A; Recommendation level 1)
2. Patients with any uncontrolled maladaptive eating disorder should be excluded. (Quality of evidence C; Recommendation level 3)
3. For the patient to be considered for any bariatric therapies, he/she should have undergone a maximum effort to his/her capacity with adequate assistance from the multi-disciplinary team for weight reduction. (Quality of evidence D; Recommendation level 3)
4. Although weight loss is always encouraged, the rapid
5-10% weight reduction typically required for bariatric surgery is not necessary for ESG procedure. (Quality of evidence C; Recommendation level 2)
5. All bariatric treatment options should be thoroughly explained to the patients. The physician’s credential should also be declared that ESG will be performed by a highly experienced physician in advanced endoscopy and/or minimally invasive surgery after a formal training for ESG. (Quality of evidence D; Recommendation level 3)
6. The committee agrees that a lower BMI cut-off than the international standard for Caucasians should be used due to the higher risk of obesity-related morbidities at a lower BMI value.19-21 (Quality of evidence B; Recommendation level 2)
7. For patients with a BMI of more than 37.5 kg/m² regardless of co-morbidities, surgery should be the primary treatment. (Quality of evidence C; Recommendation level 3)
8. For patients whose BMI is between 32.5-37.5 kg/m² with co-morbidities, surgery should be the primary treatment with ESG as an alternate option. (Quality of evidence C; Recommendation level 3)
9. ESG should be considered a primary treatment for obesity in patients whose BMI is between 32.5-
37.5 kg/m² without co-morbidities. (Quality of evidence C; Recommendation level 3)
10. The role of ESG in patients whose BMI is between
27.5-32.5 kg/m² is yet to be clearly defined and should be reevaluated once the local data becomes more available. (Quality of evidence D; Recommendation level 3)
11. ESG should be performed in tertiary care hospital where a collaborative multi-disciplinary team comprising of endocrinologists, nutritionists, bariatric surgeons, and gastroenterologists is available. (Quality of evidence C; Recommendation level 3)
12. ESG should initially be performed by expert endoscopists, defined as physicians who have been formally trained in advanced endoscopy or minimally invasive surgery, have performed ESG procedure under a formal proctorship by an expert bariatric endoscopist, and have been approved by the TAGE-TSMBS committee. (Quality of evidence D; Recommendation level 3)
13. Safety and efficacy data should commence periodically post-procedure for credentialing purposes. (Quality of evidence D; Recommendation level 3)
14. All procedures should be registered in a National Registry on Safety and Efficacy of Bariatric Endoscopy. (Quality of evidence D; Recommendation level 3)
15. Patients who have undergone ESG should have a regular follow-up with the multi-disciplinary team to assess nutrition status, continued lifestyle modification, and weight reduction efficacy. (Quality of evidence B; Recommendation level 1)
CONCLUSION
The obesity crisis in Thailand continues to rise and threaten the well-being of our population. TAGE and TSMBS recognize an urgent need to optimize and standardize available therapeutic modalities for patients with this chronic, relapsing, debilitating disease. This addendum statement aims to clarify the indication for ESG to be primarily for patients with BMI between
32.5-37.5 kg/m² without co-morbidities and emphasizes the importance of post-procedural care with a multi- disciplinary team approach. It is intended to serve as a general recommendation to safely and effectively incorporate ESG into the bariatric treatment armamentarium. As the field is still evolving, TAGE and TSMBS are committed to periodic updates on these recommendations when more local data becomes available.
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
Volume 73, No.5: 2021 Siriraj Medical Journal 291
Kongkam et al.
REFERENCES
1. Aekplakorn W, Inthawong R, Kessomboon P, Sangthong R, Chariyalertsak S, Putwatana P, et al. Prevalence and trends of obesity and association with socioeconomic status in Thai adults: National Health Examination Surveys, 1991-2009. J Obes 2014;2014:410259.
2. Jitnarin N, Kosulwat V, Rojroongwasinkul N, Boonpraderm A, Haddock C, Poston W. Prevalence of overweight and obesity in Thai population: results of the National Thai Food Consumption Survey. Eat Weight Disord 2011;16(4):e242-9.
3. All countries significantly off track to meet 2025 WHO targets on Obesity, 2020.
4. Pitayatienanan P, Butchon R, Yothasamut J, Aekplakorn W, Teerawattananon Y, Suksomboon N, et al. Economic costs of obesity in Thailand: a retrospective cost-of-illness study. BMC Health Serv Res 2014;14:146.
5. Viratanapanu I, Romyen C, Chaivanijchaya K, Sornphiphatphong S, Kattipatanapong W, Techagumpuch A, et al. Cost-effectiveness evaluation of bariatric surgery for morbidly obese with diabetes patients in Thailand. J Obes 2019;2019:5383478.
6. Techagumpuch A, Pantanakul S, Chansaenroj P, Boonyagard N, Wittayapairoch J, Poonthananiwatkul T, et al. Thai Society for Metabolic and Bariatric Surgery Consensus Guideline on Bariatric Surgery for the Treatment of Obese Patient in Thailand. J Med Assoc Thai 2020;103:300-7.
7. Benaiges Foix D, Más-Lorenzo A, Goday Arno A, Ramón Moros JM, Chillarón Jordan JJ, Pedro-Botet JC, et al. Laparoscopic sleeve gastrectomy: More than a restrictive bariatric surgery procedure? 2015.
8. Glass J, Chaudhry A, Zeeshan MS, Ramzan Z. New Era: Endoscopic treatment options in obesity–a paradigm shift. World J Gastroenterol 2019;25(32):4567-79.
9. Sartoretto A, Sui Z, Hill C, Dunlap M, Rivera AR, Khashab MA, et al. Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study. Obes Surg 2018;28:1812-21.
10. Alqahtani A, Al-Darwish A, Mahmoud AE, Alqahtani YA, Elahmedi M. Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc 2019;89:
1132-8.
11. Barrichello S, de Moura DTH, de Moura EGH, Jirapinyo P, Hoff AC, Fittipaldi-Fernandez RJ, et al. Endoscopic sleeve
gastroplasty in the management of overweight and obesity: an international multicenter study. Gastrointest Endosc 2019;90:
770-80.
12. de Moura DTH, de Moura EGH, Thompson CC. Endoscopic sleeve gastroplasty: from whence we came and where we are going. World J Gastroenterol Endosc 2019;11:322.
13. Fiorillo C, Quero G, Vix M, Guerriero L, Pizzicannella M, Lapergola A, et al. 6-month gastrointestinal quality of life (QoL) results after endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy: a propensity score analysis. Obes Surg 2020;30:1944-
51.
14. Lopez-Nava G, Negi A, Bautista-Castaño I, Rubio MA, Asokkumar R. Gut and metabolic hormones changes after endoscopic sleeve gastroplasty (ESG) vs. laparoscopic sleeve gastrectomy (LSG). Obes Surg 2020;30:2642-51.
15. Sullivan S, Kumar N, Edmundowicz SA, Dayyeh BKA, Jonnalagadda SS, Larsen M, et al. ASGE position statement on endoscopic bariatric therapies in clinical practice. Gastrointest Endosc
2015;82:767-72.
16. Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, et al. A pathway to endoscopic bariatric therapies. Gastrointest Endosc 2011;74:943-53.
17. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al.
GRADE guidelines: 1. Introduction—GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383-
94.
18. Ebell MH, Siwek J, Weiss BD, Woolf SH, Susman J, Ewigman B, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. J Am Board Fam Pract 2004;17:59-67.
19. WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004;363(9403):157-63.
20. Misra A, Chowbey P, Makkar B, Vikram N, Wasir J, Chadha D, et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India 2009;57:163-70.
21. Pan W-H, Yeh W-T. How to define obesity? Evidence-based multiple action points for public awareness, screening, and treatment: an extension of Asian-Pacific recommendations. Asia Pac J Clin Nutr 2008;17(3):370-4.
292 Volume 73, No.5: 2021 Siriraj Medical Journal https://he02.tci-thaijo.org/index.php/sirirajmedj/index