Selecting Patients for Surgery: Current guidelines fall short in determining appropriate patients who would benefit most from surgery. For instance, the recommendation that a desire to discontinue PPI therapy is a suitable indication for antireflux surgery fails to recognize that 62% of patients end up back on PPIs within 9 years.Furthermore, indicating that those patients who failed medical management would benefit from surgery neglects the fact that the patients who respond best to antireflux surgery are those who have responded well to PPI therapy in the first place
Complications: Late postoperative complaints are more common and often are referred back to the referring gastroenterologist for diagnosis and management. These include late-onset dysphagia (3%–24%), recurrent heartburn (up to 62%), gas-bloat syndrome (up to 85%), and diarrhea (18%–33%). Anatomic failure of the fundoplication (Figure Below) can present a unique challenge to the clinician because the symptoms and patient presentation (postoperative dysphagia, regurgitation, and heartburn) can be clinically indistinct from the issues seen commonly after this surgery even in the best of circumstances. Therefore, the gastroenterologist should assess symptoms carefully in a stepwise approach with upper endoscopy, barium swallow, esophageal manometry, and/or ambulatory pH monitoring when appropriate and plan any interventions based on objective findings from focused testing.
Antireflux Surgery Has No Significant Impact on the Progression of Barrett’s Esophagus to Esophageal Adenocarcinoma: Endoscopic Ablation of Dysplastic Barrett’s Esophagus Still Is Recommended
Medical Therapy Is More Cost Effective Than Surgical Treatment if the Cost of the Drug Is Low
Several New, Less-Invasive Surgical and Endoscopic Antireflux Procedures Are Now Food and Drug Administration Approved, Available, and Appear Promising
A recent prospective longitudinal cohort study (J Franken et al. JPGN 2020; 70: e41-47) examined the development of gastroesophageal reflux (GER) in 50 children who underwent gastrostomy tube (GT) placement between 2012-2014.
GER symptoms were present before and after GT placement: in 44% and 40% respectively.
Among the 25 who underwent pre- and post-operative impedance-pH analysis
there was not a significant change in acid exposure: 6.2% vs. 6.1%
there was not a significant change in reflux episodes
Prior to GT placement, 18 of 25 (72%) had pathologic reflux. Afterwards, 18 of 25 (72%) had pathologic reflux –though this included 4 with new onset reflux and 4 with resolved reflux
My take: This study shows that reflux symptoms and documented reflux are commonplace in children undergoing GT placement. Based on this limited sample size, it appears that GER does not appreciably change following GT placement.
In this retrospective study from Australia (P Jacoby et al J Pediatr 2020; 217: 131-8.), the authors analyzed two cohorts with total of 673 children with disabilities who had undergone gastrostomy tube (GT) placement.
All-cause hospitalizations declined at 5 years after procedure with combined (both cohorts) incidence rate ratio of 0.63
Admissions for lower respiratory tract infections did not change appreciably
Admissions for epilepsy were generally decreased (see Table V) –this drop is mainly what accounts for the lower hospitalization rates.
Fundoplication (which occurred in ~30% with GT insertion) “seemed to decrease the relative incidence of acute LRTI admissions in the combined cohort”
The specific numbers for hospitalizations are listed in Table V.
In their discussion, the authors noted that in the year prior to GT placement, there had been an elevated number of hospitalizations. With regard to fundoplication, the authors note uncertain benefit for respiratory complications. In previous studies of neonates and children with neurologic impairment and GT placement, there was similar gastrointestinal and respiratory related admissions with or without fundoplication.
My take: GT placement facilitates care for children with disabilities including provision of medication and nutrition. This study confirms subsequent improvement in hospitalization rates but does not show a clear benefit with regard to respiratory infections.
A recent study (SJ Spechler et al. NEJM 2019; 381: 1513-23) on first glance appears to support surgery as more effective than medical treatment for refractory heartburn.
Only ~20% of enrolled patients were included in the reported outcomes!
Here’s what happened. Among a cohort of VA patients (n=360, mean age 48 years) who were reportedly refractory to PPI-treatment:
78 were excluded during prerandomization
42 had relief of their heartburn during a 2-week omeprazole lead-in (20 mg BID)
70 did not complete trial procedures
23 had non-GERD disorders
99 had functional heartburn
This left 78 patients who underwent randomization. All patients in this highly-selected group had undergone endoscopy with biopsy, impedance-pH testing, and esophageal manometry. 18 of 27 (67%) had treatment success with surgery compared to 7 of 25 patients treated with baclofen/PPI and 3 of 26 with control medical treatment (PPI alone).
Careful evaluation is needed in any patient with refractory heartburn, especially if contemplating surgery. Most will either respond to PPI treatment or have a disorder other than reflux; the authors note that 122 patients (out of 360 patients) did NOT have reflux –99 had functional heartburn.
Careful instruction in PPI use can be helpful. Omeprazole and similar agents should be taken 30 minutes before meals.
The authors noted that in addition to reflux, that reflux hypersensitivity can “respond to fundoplication…treatment success was 71% among the 14 with reflux hypersensitivity and 62% among the 13 with abnormal acid reflux.”
Limitations: The VA population is not representative of the general population; this trial had a predominance of white males. Also, it is hard to exclude that some of the ‘success’ of the procedure could relate to a powerful placebo response.
My take: This trial reinforces the notion that reflux surgery is helpful in very few highly-selected patients.
A recent study (ME McSweeney et al. JPGN 2018; 66: 887-92) determined that preoperative characteristics were unable to determine which patients who had gastrostomy tube (GT) placement would ultimately need conversion to gastrojejunostomy (GJ) placement.
This retrospective study matched 79 GJ patients with 79 GT patients.
These patients had similar rates of successful preoperative nasogastric feeding trials (GT 84.5% vs GJ 83.1%), and similar rates of abnormal swallow studies (53.8% and 62.2% respectively).
In the entire cohort, 11 patients had fundoplication (all GJ patients)
GT patients were more likely to have tube permanently removed: 20.5% vs 2.5% for GJ patients. Many (45.6%) of the GJ converted patients went back to GT feeds
Overall, from an initial cohort of 902 patients, 8.8% “required conversion” to GJ feeds
GJ-converted patients had a trend towards fewer hospitalizations.
While not a result in the study, the issue of GJ compared with fundoplication is briefly discussed. The authors in their discussion of preoperative workup state that
“the complications of fundoplication are more significant and the risks are higher than GJ placement”
In my view, this is one of the most consequential parts of their discussion. While the authors have extensive experience, I think the issue regarding GJ tube placement and fundoplication is more murky. GJ tubes can be difficult to maintain and I have not seen long-term well-controlled studies comparing outcomes between GJ placement and fundoplication.
Other pointers in the discussion:
Fundoplication has “minimal impact/no impact” to reduce respiratory-related admissions, mainly because the main mechanism is aspiration rather than reflux
For isolated oropharyngeal dysphagia, one could argue that “an enteral tube is not indicated anymore” based on published data
My take: This is an important retrospective study that illustrates how difficult it is to know preoperatively which patients need GJ placement (or fundoplication) compared to GT placement alone. In our institution, we are reluctant to place GT placement if a patient has not demonstrated tolerance of nasogastric feeds.
A recent prospective observational study (M Aumar et al. J Pediatr 2018; 197: 116-20) examined the effect of percutaneous gastrostomy (PEG) tube placement on gastroesophageal reflux disease (GERD) over a 13 year period. This study included 326 patients, 56% who had neurologic impairment and had a median follow-up of 3.5 years (and in some cases follow-up to 15 years). GERD was defined as gastroesophageal reflux causing troublesome symptoms and/or complications. Routine pH studies or impedance were not performed.
GERD was present in 242 of 326 patients at baseline (74%). GERD appeared in 11% of patients after PEG and was aggravated in 25% with preexisting GERD.
Factors associated with worsening GERD were neurologic impairment and preexisting GERD.
53 patients (16%) required anti-reflux surgery with 22 (6%) in the year following PEG. The only factor identified with the need for surgery was neurologic impairment.
At last followup, PEG remained in place in 133 children (41%), and had been removed in 99 (30%). 94 children (29%) were deceased, including 2 from an early procedure-related complication. In those who were deceased, the vast majority occurred related to evolution or complication of their underlying disease.
The authors note that studies have shown that PEG increases GERD, but “the majority of these studies were of low methodologic quality.”
My take: Routine antireflux surgery at the time of PEG placement is NOT needed in the majority of patients, even in those with baseline GERD. Less than 20% of patients with GERD required antireflux surgery.
In a recent retrospective study (JT Krill et al. Clin Gastroenterol Hepatol 2017; 15: 675-81), the authors reinforce the notion that surgery works best for reflux patients whose symptoms respond best to medical therapy.
Background: In this study, 196 patients with normal anatomy were identified, though 81 had inadequate follow-up at 1 year. This left 115 patients (median age ~52). This study examined patients with typical reflux symptoms (regurgitation, heartburn) (n=79 of 115, 68.7%) and extraesophageal symptoms, like cough, hoarseness, and throat clearing (n=36 of 115, 31.3%). It is noted that 2/3rds of those with extraesophageal symptoms had coexisting typical GERD symptoms. Most patients had a Nissen fundoplication but some underwent a Toupet fundoplication.
91.5% of those with typical reflux symptoms (who had responded to medical therapy) were in remission at 1 year; in comparison, only 33.3% (P <.01) of those with extraesophageal symptoms along with poor response to acid suppression therapy exhibited remission following fundoplication.
“The severity of acid reflux on pH monitoring and larger hiatal hernia size were associated with a more favorable outcome at 12 months.” All patients had either abnormal pH monitoring or endoscopic esophagitis prior to surgery. Only those with severe reflux had increased likelihood of response to surgery.
Limitations: retrospective study, 81 of 196 patients were excluded due to lack of followup
My take: This study is consistent with other studies in suggesting that reflux surgery is less effective in those who do not respond to medical therapies and who have atypical symptoms.
The presentation was given by Traci Nagy who founded the FeedingTubeAwareness website, which I have been a big fan for several years. I probably recommend this website at least once everyday at work. Of course, I am not the only one familiar with this website which is why it has had more than 200,000 hits last year.
This post includes a 37 slide lecture and links to previous publications. The “open letter number one” is particularly useful and is reviewed in the slide presentation. The “open letter number two” also has some useful points, though many would disagree on the utility of testing gastric emptying before fundoplication.
My take: Look at this post -it will help you be a more effective clinician if you take care of kids with enteral tubes.
A new endoscopic technique’s efficacy has recently been reported (Gastroenterol 2015; 148: 324-33). Since this technique is not likely to be broadly applicable to the pediatric population for some time, I will not delve into all of the details.
In essence, a carefully selected group (n=129 from a screened group of 696) of adult patients with persistent regurgitation underwent transoral fundoplication; this eliminated troublesome regurgitation in 67% compared to 45% who were randomized to sham/PPI. Severe complications were rare.
Bottomline: This endoscopic procedure along with the Stretta procedure and the LINX device (using magnets) offer alternatives to surgical fundoplication in carefully-selected patients with refractory gastroesophageal reflux symptoms.
New drugs approved by FDA:
Ceftolozane (Zerbaxa) -combines a cephalosporin with a beta-lactamase inhibitor (tazobactam). Indications: complicated intra-abdominal infections (in combination with metronidazole), and complicated urinary tract infections. From FDA: FDA approves new antibacterial drug Zerbaxa
In this month’s “GI & Hepatology News,” Dr. Ben Gold and Dr. Jose Garza comment on antireflux surgery in infants (page 12) (related article on page 1 of same issue). Initial reference: JAMA Surg 2013 [doi: 10.1001/jamasurg.2013.2685]. See the following link. They comment on the lack of workup for many of these infants who undergo this major surgery and the frequent lack of involvement by pediatric gastroenterologists.