Aug. 17, 2021

Acute cholecystitis (AC) is a common disease and typically develops in patients with gallstones (acute calculous cholecystitis). Left untreated, patients with AC can develop gangrene and gallbladder perforation, both of which can be life-threatening.

The preferred treatment for AC is cholecystectomy (laparoscopic or open), a surgical procedure with a proven record of positive patient outcomes. However, some patients are poor candidates for surgery, due to advanced medical comorbidities or medical instability, ascites, or unresectable malignancy.

Options for patients who require a nonoperative or less invasive approach include treatment with antibiotics and percutaneous and endoscopic methods of gallbladder drainage, as outlined below.

Percutaneous gallbladder drainage

This procedure involves insertion of a tube that drains externally to a bag worn underneath a patient's clothes. While this approach is generally safe, patient discomfort while the drain is in place and other potential complications associated with external drainage can occur. These include drainage site discomfort or inconvenience, migration, infection, and chronic fistula formation to the skin.

Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD)

This procedure allows an endoscopist to access the gallbladder under endoscopic ultrasound guidance and place stents through the wall of the small intestine into the gallbladder to relieve the gallbladder obstruction and resulting infection.

Endoscopic retrograde cholangiopancreatography-guided transpapillary gallbladder drainage (ERGD)

This procedure involves placement of long plastic stents from the gallbladder into the small intestine using the body's natural cavities through use of endoscopic retrograde cholangiopancreatography (ERCP). Multiple stents may be placed in this natural route, and this may be a long-term alternative or bridge to gallbladder removal surgery.

A Mayo Clinic-led research team recently sought to evaluate the long-term success rates (both technical and clinical) associated with ERGD for patients who are ineligible for cholecystectomy. The results of this research were published in Gastrointestinal Endoscopy in 2021. "Our primary aim was to evaluate long-term success of destination ERGD," explains lead author Andrew C. Storm, M.D., a gastroenterologist at Mayo Clinic in Rochester, Minnesota.

Methods

The research team identified and analyzed data obtained from 51 patients with AC who were not candidates for cholecystectomy and underwent ERGD with attempted transpapillary placement of plastic double-pigtail stents between January 2008 to December 2019.

The researchers classified patients using the definitions in the Tokyo guidelines for mild, moderate or severe AC. They also defined three different categories of successful outcomes and documented the rate and interval of recurrence of cholecystitis, any need for additional interventional therapies during follow-up after ERGD, and any endoscopic procedure-related adverse events, categorized using the Cotton lexicon.

The researchers defined long-term success as the absence of AC or need for repeat therapy within six months after ERGD. Technical success was defined as placement of at least one transpapillary stent into the gallbladder. Clinical success was defined as the resolution of AC symptoms at discharge from the hospital.

Results

• Overall, 95.9% of patients (47 of 49) treated with ERGD achieved long-term success. This includes 100% of patients (31 of 31) who underwent side-by-side (double) stent placement at the initial or a subsequent ERGD procedure, and 89% of patients (16 of 18) who underwent single stent placement.
• Overall, 96.1% (49 of 51) of patients treated with ERGD achieved technical success.
• Adverse events occurred in 5.9% (3) of patients treated with ERGD.
• A survival curve illustrating time without AC symptoms after the procedure suggests that patients undergoing double-stent placement experienced a longer time to recurrence of AC than those undergoing single-stent placement (P = 0.13). And fewer repeat procedures were performed in patients undergoing double-stent placement than in patients undergoing single-stent placement (P = 0.045).

Conclusions and related research

"Our findings suggest that transpapillary ERGD with double-pigtail stent placement is a safe and effective long-term therapy for patients with acute cholecystitis who are poor candidates for surgery," explains Dr. Storm. "In these patients, we have determined that placing pigtail stents into the gallbladder during an ERCP procedure results in long-term palliation of their symptoms, and in many cases these patients will require no further procedures during their lifetime.

"Although double-stent therapy is not always technically feasible, this approach can be used to salvage failed single-stent therapy or recurrence after elective stent removal, and it may therefore be the preferred treatment modality for nonsurgical treatment of acute cholecystitis."

Dr. Storm notes that Mayo Clinic researchers are also currently studying how the external drains used during percutaneous drainage procedures impact patient quality of life. "We know that, in general, these external drains are cumbersome and generally disliked by our patients. So the fact that this ERCP-guided approach facilitates gallbladder drainage internally is really a big improvement for our patients."

In another study, Mayo Clinic researchers are examining the efficacy of EUS-GBD in the management of AC. "This approach may be an alternative for patients who don't respond to ERCP-guided gallbladder drainage," says Dr. Storm. "Our multicenter prospective clinical study should be concluding during 2021, and we're excited to see the results and add that procedure to our list of options for patients with cholecystitis who are not candidates for cholecystectomy or for patients who wish to avoid surgery."

For more information

Storm AC, et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointestinal Endoscopy. In press.