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Doctoral Thesis
DOI
https://doi.org/10.11606/T.5.2021.tde-11082021-130350
Document
Author
Full name
Vítor Ottoboni Brunaldi
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2021
Supervisor
Committee
Moura, Eduardo Guimarães Hourneaux de (President)
Malheiros, Carlos Alberto
Santos, José Sebastião dos
Szor, Daniel José
Title in Portuguese
Ensaio clínico randomizado do tratamento endoscópico do reganho de peso pós derivação gástrica em Y de Roux através da moldagem da anastomose gastrojejunal com plasma de argônio isolado versus plasma de argônio associado à sutura endoscópica
Keywords in Portuguese
Cirurgia bariátrica
Coagulação com plasma de argônio
Derivação gástrica
Endoscopia
Obesidade
Técnicas de sutura
Abstract in Portuguese
Introdução: uma parcela não desprezível dos pacientes recupera peso após a derivação gástrica em Y-de-Roux (DGYR). Tanto a eletrofulguração com plasma de argônio (APC) isolada quanto APC associada à sutura endoscópica de espessura total (APC-SET) já foram relatadas no tratamento do reganho de peso associado à dilatação da anastomose gastrojejunal. No entanto, ainda faltam dados comparativos controlados entre essas técnicas. Objetivo: comparar APC e APC-SET em termos de eficácia e segurança no tratamento do reganho de peso pós-DGYR e avaliar preditores de sucesso clínico. Métodos: realizou-se ensaio clínico randomizado, aberto, de centro único, comparando diretamente estes dois métodos. Pacientes com pelo menos 20% de recuperação de peso em relação ao nadir e anastomose >= 15 mm foram considerados elegíveis. O desfecho primário foi a perda percentual total do peso (PPTP) em 12 meses. Os desfechos secundários foram a incidência de eventos adversos, melhora dos parâmetros laboratoriais metabólicos e melhora na qualidade de vida (QV) e comportamento alimentar. Resultados: quarenta pacientes elegíveis foram incluídos de outubro de 2017 a julho de 2018. As taxas de sucesso técnico e clínico foram semelhantes entre os grupos. Aos 12 meses, a PPTP média foi de 8,3 ± 5,5 no grupo APC versus 7,5 ± 7,7% no grupo APC-SET (p = 0,71). A porcentagem de retenção gástrica para sólidos pré-revisional 1 hora após ingesta correlacionou-se positivamente com a probabilidade de atingir >= 10% PPTP em 12 meses. Ambos os grupos experimentaram reduções significativas nos níveis de LDL e triglicerídeos em 12 meses, e melhora no comportamento alimentar e QV em 3 meses. Houve 2 casos de estenoses (um de cada grupo) tratados com sucesso com dilatação endoscópica por balão. Conclusão: a APC isolada e APC-SET são semelhantes em termos de resultados técnicos e clínicos dentro de um ano de acompanhamento
Title in English
Argon plasma coagulation alone versus APC plus full-thickness endoscopic suturing to treat weight regain following Roux-en-Y Gastric Bypass: a prospective randomized trial
Keywords in English
Argon plasma coagulation
Bariatric surgery
Endoscopy
Gastric bypass
Obesity
Suture techniques
Abstract in English
Introduction: a non-negligible portion of patients regain weight following Roux-en-Y gastric bypass (RYGB). Both ablation with Argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone have been reported at treating weight regain when associated with gastrojejunostomy (GJ) dilation. However, comparative controlled data still lack. Aims: to compare APC versus FTS-APC in terms of efficacy and safety within 12 months of follow-up. Methods: this was a pilot single-center open-label randomized trial comparing these methods in performing transoral outlet reduction. Patients with at least 20% weight regain from the nadir, and GJ >= 15mm were considered eligible. The primary outcome was % total weight loss (%TWL) at 12 months. Secondary outcomes were the incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life (QOL) and eating behavior. Results: Forty patients meeting eligibility criteria were enrolled from October 2017 to July 2018. Technical and clinical success rates were similar between groups. At 12 months, the mean %TWL was 8.3 ± 5.5 in the APC alone group versus 7.5 ± 7.7% in the FTS-APC group (p=0.71). The pre-revisional % solid gastric retention at 1 hour positively correlated with the probability of achieving >= 10% TWL at 12 months. Both groups experienced significant reductions in LDL and triglycerides levels at 12 months, and improvement in eating behavior and QOL at 3 months. There were 2 cases of stenoses (one from each group) successfully treated with endoscopic balloon dilation. Conclusion: the APC alone is similar to the FTS-APC in terms of technical and clinical outcomes within one year of follow-up
 
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Publishing Date
2021-08-13
 
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