As noted in a previous post, Biliary Dyskinesia –“Only in America” | gutsandgrowth, gallbladder dykinesia is a quite dubious diagnosis. A recent pediatric study (PM Jones et al. JPGN 2016; 63: 71-75) adds to the uncertainty.
This study utilized a large database for a retrospective review of HIDA scans in patients <22 years. In a group of 2558 patients, 310 patients had a full-text gallbladder pathology report paired with HIDA scan. The majority of these HIDA scans (64.5%) were performed in teenage Caucasian girls. Key finding:
- Gallbladder ejection fraction (GBEF) did not correlate with the presence of gallbladder pathology. The Odd Ratio (OR) for cholecystitis with EF of 16-34 was 0.98.
- The majority had at least microscopic pathology: 71.6% had microscopic cholecystitis
The authors indicate that other studies have shown that the diagnosis of gallbladder dyskinesia is controversial “because some point to the strong placebo effect of a surgical intervention, as well as the finding that patients who were observed for a year or more had similar symptom improvement compared with those who had an operation.” [J Pediatric Surg 2006; 41: 1894-8]
Ultimately, the utility of HIDA scans can only be addressed with randomized prospective studies. Perhaps, these studies will show that HIDA scans are not predictive of who needs a cholecystectomy.
My take: It is interesting that pathology did not correlate with HIDA results. However, the bigger question is whether abnormal gallbladder function, as assessed by HIDA, triggers symptoms that merit cholecystectomy. This is not addressed by this study.
What are the changes in Rome IV for children and adolescents? JS Hyams, C DiLorenzo et al (Gastroenterol 2016; 150: 1456-68) provide a helpful review.
The ‘dictum’ that there was “no evidence for organic disease” as an criteria for functional disorders has been dropped in favor of “after appropriate medical evaluation the symptoms cannot be attributed to another medical condition.” This subtle change discourages excessive investigations.
The functional disorders covered in this article include
- H1 Functional nausea and vomiting disorders: H1a -cyclic vomiting syndrome, H1b -functional nausea and vomiting (NEW), H1c -rumination syndrome, H1d -aerophagia
- H2 Functional abdominal pain disorders: H2a -functional dyspepsia, H2b -irritable bowel syndrome, H2c -abdominal migraine, H2d -functional abdominal pain -not otherwise specified
- H3 Functional defecation disorders: H3a -functional constipation, H3b -nonretentive fecal incontinence
- “There are no published data on the treatment of isolated functional nausea and isolated functional vomiting”
- “We have eliminated the requirement of pain to fulfill the criteria for FD” [functional dyspepsia]
- Criteria for cyclic vomiting and abdominal migraines now require only 2 episodes in a 6 month period
- Criteria for functional constipation requires only 1 month rather than 2 months (this is true for H3b as well). The authors endorsed the NASPGHAN expert guidelines which included “no role for routine use of an abdominal x-ray to diagnose FC.” The guideline discourages testing for cow’s milk allergy, hypothyroidism, celiac disease and hypercalcemia in the absence of alarm symptoms.
In a separate article, MA Benninga, S Nurko et al (Gastroenterol 2016; 150: 1443-55) describe the functional disorders affecting infants and toddlers.
In my view, the article in this special edition that incorporates the most changes regards functional disorders of the biliary tree (FGBD) (PB Cotton et al Gastroenterol 2016; 150: 1420-29). This is mainly due to data showing that sphincterotomy is no better than sham treatment for patients with post-cholecystectomy pain. “The concept of sphincter of Oddi dysfunction type III is discarded.” In addition, for biliary pain/’gallbladder dyskinesia,’ the authors also acknowledge that the role of obtaining a gallbladder ejection fraction is “controversial.” “Symptoms suggestive of FGBD often resolve spontaneously so that early intervention is unwarranted.” Ultimately, the authors state that “treatment recommendations are not firmly evidence-based.”
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When parents make up diseases in their children, the consequences can be dire. What happens when doctors find out that a disease that they have been treating probably doesn’t exist?
- Cotton PD et al. “Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial” JAMA 2014; 311: 2101-2109.
A detailed analysis of this study (Gastroenterol 2015; 148: 440-44) and the author’s reply provides some insight into that questions and helps place this study and its results into context.
Key points from the Gastroenterology Selected Summary:
- “Sphincter of Oddi dysfunction (SOD) is the term used to describe an episodic abdominal pain syndrome, typically occurring in young to middle-aged women in the setting of prior cholecystectomy…SOD remains a diagnosis of exclusion.”
- “The investigators conducted a double-blind, sham-controlled, randomized trial at 7 US tertiary centers, enrolling 214 adult post-cholecystectomy patients with debilitating abdominal pain due to suspected biliary SOD (predominantly type III).” Sham patients underwent ERCP, manometry, and pancreatic duct stenting.
- Patients were randomized 2:1 to sphincterotomy or sham; those randomized to sphincterotomy and subsequently shown to have a hypertensive pancreatic sphincter were then re-randomized (1:1) to have biliary or combined biliary/pancreatic sphincterotomies.
- “Most patients in both study groups experienced considerable reduction in their pain disability scores…the proportion meeting the trial’s 1-year primary endpoint was higher among those treated with sham compared with sphincter ablation (37% vs. 23%, P=.01)”
- “The manometry findings did not predict treatment success.” There were no other useful predictors of success identified (eg. elevated liver enzymes, prior stone at cholecystectomy)
- Adverse effects from procedures included 26 cases of acute pancreatitis (2 severe) and 2 perforations.
- “The results of this trial are fascinating…the authors, many of whom had dedicated entire careers to the management of these patients using the very procedure they have now conclusively shown to be futile, may be understandably disheartened by the results.”
- Numerous limitations of the study are noted. In particular, “the 1-year time frame of the trial is likely to have been too short to capture the deleterious impact of prophylactic pancreatic duct stenting, which…has been associated with interval induction of pancreatic ductal abnormalities mimicking chronic pancreatitis.”
- “It is our view that the authors’ data…provide an unambiguous mandate for imposing an immediate moratorium on subjecting this group of patients to ERCP.“
Dr. Cotton’s reply:
- “It may be premature to discard the whole concept of sphincter dysfunction as a cause of pain.”
- He indicates that “gallbladder dyskinesia” is another related question and was the reason for surgery in half of EPISOD subjects.
- The results of the study “clearly show the need for equally stringent studies to answer the many remaining questions.”
For those who read this much of this post: I wanted to let you know that yesterday’s online post on early peanut introduction was updated with recommendations from the associated editorial.
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Another headline from Freaknomics Website follows. Of course I probably should think twice about poking fun at typos given the volume of them on this blog.