A surgeon and gastroenterologist team from the University of California, Irvine, has developed a new approach for the treatment of reflux disorders.
The procedure, concomitant transoral incisionless fundoplication (cTIF), pairs a laparoscopic hiatal hernia repair with TIF in a single session.
For the fundoplication, physicians endoscopically create a modified surgical antireflux valve, called an omega valve. The valve can be adapted for laparoscopic fundoplication or cTIF. Investigators believe the omega valve forms a durable barrier to reflux, with fewer symptoms than those associated with a traditional Nissen fundoplication.
Investigators hope cTIF and omega fundoplication will lead to better repairs and open the door to endoscopic and surgical treatment for more patients suffering from GERD and hiatal hernias.
“I think our new innovative approaches will change the way we perform antireflux surgery, and maybe we’ll see a change in acceptance of these procedures similar to the acceptance and growth of bariatric surgery in the early 2000s,” said Ninh Nguyen, MD, the chair of surgery at the University of California, Irvine.
In the Journal of the American College of Surgeons, Dr. Nguyen and Kenneth Chang, MD, a professor and the chief of gastroenterology at UC Irvine, reported the results of cTIF in 60 patients with confirmed GERD and hiatal hernias larger than 2 cm (2021;232[3]:309-318). In this group, 53% were men with a mean age of 59.3 years, and all were treated between 2018 and 2020.
The surgeon first performs laparoscopic hiatal hernia repair, followed by a same-session TIF by the gastroenterologist, for a combined procedure that lasts about 90 minutes.
Although cTIF was technically successful in all cases, one patient experienced an esophageal mucosal tear with subsequent mediastinal inflammation during the TIF portion, which investigators attributed to excessive torquing of the TIF device.
Assessments showed that patients’ symptoms significantly improved six months after treatment. Their scores on the Reflux Disease Questionnaire dropped to around one-third of baseline. GERD health-related quality-of-life scores for gas bloating decreased to 0.25 at six months and 0.5 at 12 months, from 1.4 at baseline. Heartburn also dropped significantly. Use of proton pump inhibitors fell from 69% to 29% of patients at six months and to 14% at 12 months.
The results, however, are based on small numbers of patients. Six months after cTIF, only 30% of patients completed the Reflux Disease Questionnaire, and 20% and 18%, respectively, were evaluated with the Reflux Symptom Index and the GERD-Health-Related Quality of Life assessment.
Ambulatory pH monitoring after cTIF was available in five patients, with DeMeester scores improving from 49.1 to 4.9 after the procedure, and mean acid exposure time improving from 12.7% at baseline to 1.28%.
Over the past decade, studies have shown that TIF is a safe antireflux procedure for GERD refractory to medical therapy. It is not as effective as laparoscopic fundoplication for preventing gastroesophageal reflux, and its application is limited to patients without hiatal hernias. But TIF is appealing to patients who prefer to avoid surgery with its reduced risk for post-procedure pain and overnight hospital stay, and no scar.
Dr. Nguyen said he and Dr. Chang believe the addition of the hiatal hernia repair strengthens the antireflux barrier and increases the length of the intraabdominal esophageal segment to reestablish the gastroesophageal flap valve. It also means that patients with a hiatal hernia can undergo an endoscopic antireflux procedure.
Since their report, Drs. Nguyen and Chang expanded their cTIF eligibility to include patients with hiatal hernias smaller than 2 cm.
In an accompanying editorial, Kyle A. Perry, MD, an associate professor of surgery at The Ohio State University Wexner Medical Center, in Columbus, said cTIF offers the “potential of an elusive high-efficacy, lower side effect management strategy for GERD patients.”
But there are important unanswered questions, he added. The long-term durability of cTIF remains unknown, especially compared with laparoscopic Nissen fundoplication. The side effects need to be examined in more patients, he added.
It’s not clear that cTIF will appeal to clinicians and patients, given that patients still need a surgical procedure. Moreover, the fundoplication is held together with plastic fasteners rather than sutures, noted Ezra Teitelbaum, MD, an assistant professor of surgery at Northwestern University Feinberg School of Medicine, in Chicago.
“I think the big question now becomes what is the comparison between cTIF and other ways of creating the antireflux barrier at the time of surgery,” he said. “Can it provide the same degree of reflux control? How does it compare with Toupet in terms of dysphagia and gas bloat?”
He said cTIF should be tested head-to-head in randomized studies with Toupet fundoplication.
Investigators are trying to get larger studies underway. They are seeking institutional review board approval for a multicenter randomized trial that will compare cTIF with laparoscopic Nissen fundoplication, Dr. Nguyen said. He pointed out that there is a learning curve associated with TIF and cTIF, and these procedures require specialized training.
Michael Ujiki, MD, the Louis W. Biegler Chair of Surgery at NorthShore University HealthSystem, in Chicago, said he agreed with the authors that endoscopy is a critical step in antireflux procedures. But he challenged the suggestion that laparoscopic fundoplication doesn’t afford an endoscopic view.
“Just placing the scope [during laparoscopic fundoplication] does that,” he said, adding that all surgeons who perform antireflux procedures should employ endoscopy during the operation.
“You can better visualize the valve you’re creating, make sure that you are creating it at the right place on the esophagus, and then also ensure that it has the right compliance—not too tight, not too loose,” he said.
The work of Drs. Nguyen and Chang on cTIF also led to modifications in their construction of the surgical gastro-esophageal flap valve, which they hope will improve surgical outcomes.
They describe the omega flap valve in detail in the March issue of Surgical Endoscopy (2021 Mar 11. doi:10.1007/s00464-021-08416-y). The wrap begins at the angle of His at the 3 o’clock position, with a near circumferential wrap of distal esophagus, leaving open the backstop region along the lesser curvature. This approach will allow for physiologic venting and reduce the risk for dysphasia and gas bloat, Drs. Nguyen and Chang wrote.
“We’re not trying to create a new operation. The current fundoplication operations are good operations. All you have to do is change your technique a little bit to improve the formation, and hence the efficacy, of the omega valve,” Dr. Nguyen said.
The omega fundoplication involves two technical differences from conventional approaches: a partial fundoplication with orientation in a reverse C fashion, and the gastric cardia wrap oriented toward the 9 o’clock position rather than the conventional approach of 11 or 12 o’clock position; and placing initial sutures to reestablish the angle of His, followed by using the mid-aspect of the anterior and posterior gastric wall to perform the 300-degree wrap. The omega fundoplication is a partial wrap that leaves a 60-degree area of the esophagus open along the lesser curvature.
This valve may offer a surgical approach to the formation of the omega valve for surgeons who do not want to adopt cTIF, Dr. Nguyen said.
Dr. Teitelbaum said the omega fundoplication has promise as a laparoscopic antireflux procedure. “I think it’s a very interesting idea, especially how they think it might be more reproducible,” he said. “That makes sense to me.”
—Christina Frangou
Dr. Nguyen’s institution received grant funding for evaluating the role of cTIF followed by sleeve gastrectomy, and he reported consulting fees from EndoGastric Solutions and Olympus. Dr. Chang reported consulting fees and other payments from Apollo Endosurgery, and his institute receives grant funding from Cook Medical, EndoGastric Solutions Inc., Erbe and Olympus.
This article is from the June 2021 print issue.