Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) each led to good and sustainable weight loss 10 years later, although reflux was more prevalent after SG, according to the Sleeve vs Bypass (SLEEVEPASS) randomized clinical trial.
At 10 years, there were no statistically significant between-procedure differences in type 2 diabetes remission, dyslipidemia, or obstructive sleep apnea, but hypertension remission was greater with RYGB.
However, importantly, the cumulative incidence of Barrett’s esophagus was similar after both procedures (4%) and markedly lower than reported in previous trials (14%-17%).
To their knowledge, this is the largest randomized controlled trial with the longest follow-up comparing these two laparoscopic bariatric surgeries, Paulina Salminen, MD, PhD, and colleagues write in their study published online in JAMA Surgery.
They aimed to clarify the “controversial issues” of long-term gastroesophageal reflux disease (GERD) symptoms, endoscopic esophagitis, and Barrett’s esophagus after SG vs RYGB.
The findings showed that “there was no difference in the prevalence of Barrett’s esophagus, contrary to previous reports of alarming rates of Barrett’s [esophagus] after sleeve gastrectomy,” Salminen, from Turku University Hospital, Turku, Finland, told Medscape Medical News in an email.
“However, our results also show that esophagitis and GERD symptoms are significantly more prevalent after sleeve [gastrectomy], and GERD is an important factor to be considered in the preoperative assessment of bariatric surgery and procedure choice,” she said.
The takeaway is that “we have two good procedures providing good and sustainable 10-year results for both weight loss and remission of comorbidities” for severe obesity, a major health risk, Salminen summarized.
10-Year Data Analysis
Long-term outcomes from randomized clinical trials of laparoscopic SG vs RYGB are limited, and recent studies have shown a high incidence of worsening of de novo GERD, esophagitis, and Barrett’s esophagus, after laparoscopic SG, Salminen and colleagues write.
To investigate, they analyzed 10-year data from SLEEVEPASS, which had randomized 240 adult patients with severe obesity to either SG or RYGB at three hospitals in Finland during 2008-2010.
At baseline, 121 patients were randomized to SG and 119 to RYGB. They had a mean age of 48 years, a mean BMI of 45.9 kg/m2, and 70% were women.
Two patients never had the surgery, and at 10 years, 10 patients had died of causes unrelated to bariatric surgery.
At 10 years, 193 of the 288 remaining patients (85%) completed the follow-up for weight loss and other comorbidity outcomes, and 176 of 228 (77%) underwent gastroscopy.
The primary study endpoint of the trial was percent excess weight loss (%EWL). At 10 years, the median %EWL was 43.5% after SG vs 50.7% after RYGB, with a wide range for both procedures (roughly 2%-110% excess weight loss). Mean estimate %EWL was not equivalent, with it being 8.4% in favor of RYGB.
After SG and RYGB, there were no statistically significant differences in type 2 diabetes remission (26% and 33%, respectively), dyslipidemia (19% and 35%, respectively), or obstructive sleep apnea (16% and 31%, respectively).
Hypertension remission was superior after RYGB (8% vs 24%; P = .04).
Esophagitis was more prevalent after SG (31% vs 7%; P < .001).
‘Very Important Study’
“This is a very important study, the first to report 10-year results of a randomized controlled trial comparing the two most frequently used bariatric operations, SG and RYGB,” Beat Peter Müller, MD, MBA, and Adrian Billeter, MD, PhD, who were not involved with this research, told Medscape in an email.
“The results will have a major impact on the future of bariatric surgery,” according to Müller and Billeter, from Heidelberg University, Heidelberg, Germany.
The most relevant findings are the GERD outcomes, they said. Because of the high rate of upper endoscopies at 10 years (73%), the study allowed a good assessment of this.
“While this study confirms that SG is a GERD-prone procedure, it clearly demonstrates that GERD after SG does not induce severe esophagitis and Barrett’s esophagus,” they said.
Most importantly, the rate of Barrett’s esophagus, the precursor lesion of adenocarcinomas of the esophago-gastric junction is similar (4%) after both operations and there was no dysplasia in either group, they stressed.
“The main problem after SG remains new-onset GERD, for which still no predictive parameter exists,” according to Müller and Billeter.
“The take home message … is that GERD after SG is generally mild and the risk of Barrett’s esophagus is equally higher after SG and RYGB,” they said. “Therefore, all patients after any bariatric operations should undergo regular upper endoscopies.”
However, “RYGB still leads to an increase in proton-pump inhibitor use, despite RYGB being one of the most effective anti-reflux procedures,” they said. “This finding needs further investigation.”
Furthermore, “a 4% Barrett esophagus rate 10 years after RYGB is troublesome, and the reasons should be investigated,” they added.
“Another relevant finding is that after 10 years, RYGB has a statistically better weight loss, which reaches the primary endpoint of the SLEEVEPASS trial for the first time,” they noted, yet the clinical relevance of this is not clear, since there was no difference in resolution of comorbidities, except for hypertension.
Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, Texas, who was not involved with this research, agreed that “the study shows durable and good weight loss for either type of laparoscopic surgery with important metabolic effects and confirms the long-term benefits of weight-loss surgery.”
“What is somewhat new is the lower levels of Barrett’s esophagus after sleeve gastrectomy compared with several earlier studies,” he told Medscape in an email.
“This is somewhat incongruent with the relatively high incidence of post-sleeve esophagitis noted in the study, which is an accepted risk factor for Barrett’s esophagus,” he continued. “Thus, I believe concern will still remain about GERD-related complications, including Barrett’s [esophagus], after sleeve gastrectomy.”
“This paper highlights the need for larger prospective studies, especially those that include diverse, older populations with multiple risk factors for Barrett’s esophagus,” Ketwaroo said.
Using a large data set, such as that from SLEEVEPASS and possibly with data from the SM-BOSS trial and the BariSurg trial, with machine learning and other sophisticated analyses might identify parameters that could be used to choose the best operation for an individual patient, Salminen speculated.
“I think what we have learned for these long-term follow-up results is that GERD assessment should be a part of the preoperative assessment, and for patients who have preoperative GERD symptoms and GERD-related endoscopic findings (eg, hiatal hernia), gastric bypass would be a more optimal procedure choice, if there are no contraindications for it,” she said.
Patient discussions should also cover “long-term symptoms, for example, abdominal pain after RYGB,” she added.
“I am looking forward to our future 20-year follow-up results,” Salminen said, “which will shed more light on this topic of postoperative [endoscopic] surveillance.
In the meantime, “preoperative gastroscopy is necessary and beneficial, at least when considering sleeve gastrectomy,” she said.
The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation, the Government Research Foundation (in a grant awarded to Turku University Hospital), the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation. Salminen reported receiving grants from the Government Research Foundation awarded to Turku University Hospital and the Mary and Georg C. Ehrnrooth Foundation. Another co-author received grants from the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation during the study. No other disclosures were reported.
JAMA Surgery. Published online June 22, 2022. Abstract.
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