Doing “LESS” is Beneficial -Combining ERCP and Cholecystectomy

A recent retrospective study (DS Fishman et al. JPGN 2020; 71: 203-207) identified 25 patients who underwent combined Laparascopic cholecystectomy/ERCP in Same Session (=LESS) to more conventional ERCP followed by laparoscopic cholecystectomy (n=42).  The center utilized prospectively-collected data from 13 centers and 67 consecutive ERCPs.

Key findings:

  • Median hospital stay was shorter for LESS patients, 3 days vs. 4 days (P=.32)
  • Total procedure time was similar, though a decrease in total anesthesia time was reported for LESS patients: mean 177 minutes compared to 205 minutes (P=.04)
  • No significant adverse events were reported in either group, though both groups had two patients who required repeat care due to suspected retained stones
  • The authors note that concerns about gaseous distention following ERCP “is likely unfounded as all cholecystectomies were completed.”
  • No local or systemic infections were reported.  The authors recommend antibiotic prophylaxis with the LESS approach

My take: Given the recommendation that cholecystectomy should take place during the same hospitalization for patients with choledocholithiasis, this combined approach makes a lot sense and is supported by this study.

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Isle of Palms, SC

Pediatric Experience with Presumed Biliary Dyskinesia

A recent study (SR Matta et al. JPGN 2018; 66: 808-10) highlights the frequency of cholecystectomies for “presumed biliary dyskinesia” in the United States.

Using a nationwide inpatient database, the authors examined the indication for cholecystectomy in the pediatric population from 2002 to 2011.

Key findings:

  • During the study period, the authors identified 66,380 cholecystectomies in children.  The leading indications were calculus cholecystitis (73.6%), biliary dyskinesia (10.8%), and chronic cholecystitis without calculus.
  • The frequency of biliary dyskinesia as the indication for cholecystectomy jumped significantly during the study period, particularly the first few years: 6.6% (2002), 7.8% (2003), 9.8% (2004), 10.4% (2005 & 2006), 9.9% (2007), 11.8% (2008), 9.6% (2009), 11.9% (2010), and 10.6% (2011).
  • 75% of cases were children >12 years, and 77.5% were females.

The results from the study and the way that biliary dyskinesia is controversial are reviewed in the discussion.

  • A large proportion of biliary dyskinesia patients will develop symptoms suggestive of another functional GI disorder
  • Long-term resolution of symptoms with cholecystectomy is highly variable after surgery and “55-85% of  children with biliary dyskinesia will improve with medical management.”
  • Prospective studies are lacking, but some retrospective studies have recommended using lower cut off values for ejection fraction(eg. <15-% instead of <35%); whereas, other studies have shown no correlation between ejection fraction and outcomes.

My take: Sometimes a ‘quick fix’ is not a fix at all. As this study notes, it is difficult to rely on the diagnosis of biliary dyskinesia.  Many will improve without surgery and many develop divergent symptoms.

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Which patients with asymptomatic gallstones need a cholecystectomy?

Update: re: Yesterday’s post on tax inversion.  NPR report: Pfizer calls off Allergan Merger due to anti-inversion rules instituted by Treasury Dept


“Generally, the clinical course for the majority of gallstones is asymptomatic…Overall, little knowledge exists about the development into symptomatic disease.”  This introduction from a recent study (DM Shabanzadeh et al. Gastroenterol 2016; 150: 156-67-thanks to Ben Gold for sharing his interest in this study) provides the rationale for their study which analyzed 3 randomly selected groups in Denmark (ages 30-70 years) and followed them for a median of 17.4 years.

Out of an initial 6037 participants, 664 had gallstones at baseline (after excluding 189 who had cholecystectomy and 5180 without gallstones). Only 10% were aware that they had gallstones.

Key findings: 

19.6% developed symptomatic disease (8% complicated, 11.6% uncomplicated)

Risks for symptomatic disease: Female sex, Younger age, Stone size >10 mm, Multiple stones

  • Male with small stone: 2/67 (HR 1.0)
  • Male with multiple stones: 4/97 (HR 1.83)
  • Male with large stone: 2/47 (HR 2.79)
  • Male with multiple and large stones: 3/29 (HR 5.12)
  • Female with small stone: 4/102 (HR 2.16)
  • Female with multiples stones (no large stones) 11/120 (HR 3.96)
  • Female with large stone: 12/67 (HR 6.02)
  • Highest risk: female with multiple stones and with largest stone >10 mm: 10/53(HR 11.05)

Interestingly, the 10% who knew that they had gallstones before randomly being selected  into the study had significantly higher rates of all outcomes, especially uncomplicated events.  “This finding may reflect a protopathic bias.” Patients who were aware were more likely to have suffered bilary colic attacks before study entry and thus had a higher risk of events.

My take: First of all, completion of this study over more than 17 years is an astonishing feat, particularly without informing the participants of their gallstone status.  In patients who are truly asymptomatic, my interpretation would be that only those at substantial risk would benefit from cholecystectomy.  This study does not account for other factors that could favor cholecystectomy (in asymptomatic patients) such as hemolytic diseases (e.g. sickle cell), cystic fibrosis, and other conditions in which symptomatic gallbladder disease is more likely to develop.

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Hunter Museum, Chattanooga

Hunter Museum, Chattanooga

Intervention in Gallbladder Disease

A recent review (Baron TD, et al. NEJM 2015; 373: 357-65) provides a useful review of surgical and interventional approaches to gallbladder disease.

One recommendation in particular caught my attention:

Recent data favor early laparoscopic cholecystectomy over medical management with delayed cholecystectomy. In one randomized trial involving patients with uncomplicated acute cholecystitis, laparoscopic cholecystectomy, when performed within 24 hours after the onset of cholecystitis, significantly reduced morbidity, length of hospital stay, and costs without increasing the need for conversion to open surgery.” (References: JAMA Surg 2015; 150: 129-36, Ann Surg 2013; 258: 385-93)

The authors’ Table 1 provides diagnostic guidelines and disease severity guidelines.

  • Grade 1 (mild): acute cholecystitis in otherwise healthy patient with mild local inflammatory changes and without organ dysfunction
  • Grade 2 (moderate) any of the following: leukocytosis >18K, palpable tender mass in RUQ, symptom duration >72 hr, marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis)
  • Grade 3 (severe) any of the following: hypotension requiring dopamine or norepinephrine, decreased consciousness, hypoxia, oliguria or creatinine >2.0 mg/dL, INR >1.5, or platelet count <100K

The review highlights the NOTES procedure, percutaneous cholecystotomy, and peroral endoscopic drainage (transpapillary vs. transmural).

Related blog post: Early Surgery For Acute Cholecystitis

Grand Tetons from Jackson Lodge

Grand Tetons from Jackson Lodge

Early Surgery for Acute Uncomplicated Cholecystitis

Data in adults suggests that early surgery is the best approach for acute uncomplicated cholecystitis:

From the following link: Early cholecystectomy beats delayed in acute cholecystitis : Internal : Acute cholecystitis patients fared significantly better with early rather than delayed laparoscopic cholecystectomy in the largest-ever randomized trial addressing surgical timing for this common condition.

Patients assigned to early cholecystectomy – that is, surgery within 24 hours of presentation to the hospital – had one-third the morbidity, markedly shorter hospital lengths of stay, and correspondingly lower hospital costs compared with patients who underwent surgery on day 7-45, according to Dr. Markus W. Buchler of Heidelberg (Ger.) University….

The optimal timing of surgical intervention in acute cholecystitis is a subject of long-standing controversy. The ACDC trial was conducted because in a Cochrane review of five smaller randomized trials totaling 451 acute cholecystitis patients, researchers concluded there was insufficient evidence to say which surgical strategy was best (Cochrane Database Syst. Rev. 2006 Oct 18;4:CD005440).

Dr. Buchler noted that surveys indicate many American surgeons prefer to delay laparoscopic cholecystectomy, while in Germany the surgical preference is for immediate surgery in patients with uncomplicated acute cholecystitis.

The ACDC trial involved 618 patients with uncomplicated acute cholecystitis who were placed on the same antibiotic – moxifloxacin – and randomized to early laparoscopic cholecystectomy or to delayed surgery on day 7-45. Pregnant patients were excluded from the trial, which was conducted at 35 European hospitals, including seven German university medical centers. All participating hospitals were staffed by surgical teams experienced in performing difficult laparoscopic cholecystectomies.

The primary endpoint was total morbidity within 75 days. This included cholangitis, pancreatitis, biliary leak, stroke, myocardial infarction, abscess, bleeding, peritonitis, infection, and renal failure. The rate was 11.6% in the early cholecystectomy group compared with 31.3% with delayed surgery. Among less challenging patients with an ASA score of 2 or less, the rates were 9.7% and 28.6%, respectively. Patients with an ASA score above 2 had an overall morbidity rate of 20% with early surgery compared with 47% with delayed laparoscopic cholecystectomy.

The rate of conversion to open surgery was 9.9% in the early laparoscopic cholecystectomy group and similar at 11.9% in the delayed surgery group…Total hospital stays averaged 5.4 days in the early surgery group compared with 10.0 days with delayed surgery. Mean total hospital costs calculated via the German DRG system were 2,919 euro in the early cholecystectomy group and 4,261 euro with delayed surgery.

Discussant Dr. Andrew L. Warshaw…“There’s no doubt in my mind that immediate cholecystectomy is superior in this patient population,” said Dr. Warshaw, professor and chairman of the department of surgery at Harvard Medical School, Boston.

Will NOTES come to pediatrics?

Natural orifice translumenal endoscopic surgery (NOTES) has been receiving increasing attention and is being considered as a potential alternative to laparascopic surgery; but it will be a long time before NOTES comes to pediatrics.  Initial studies for several indications have been published in the last few years and this experience has recently been reviewed (Gastroenterology 2012; 142: 704-10).

Potential operations include the following:

  • Cholecystectomy.  This has been accomplished transgastric and transvaginally.  One multicenter study published experience with 362 transgastric cases and another with 551 transvaginal cases.
  • Thyroidectomy via a translingual approach.
  • Esophageal myotomy via a transesophageal approach.
  • Appendectomy via a transvaginal approach.
  • Rectal cancer resection via a transrectal approach.

Thus far, complications have been low & no deaths; only infrequently has a laparascopic or open procedure been needed to salvage the operation.  The main limitation to further use of NOTES has been adequate instrumentation and a critical mass of investigators to explore this technique.  As expertise develops in this area, a much larger number of procedures will be undertaken.  In many ways, NOTES is akin to laparascopy in its early days.  Potential advantages of decreased pain and faster recovery are the motivation to continue to work on NOTES.