Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage (PEG)

Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial

This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.

Study Overview

• Status: Recruiting
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Procedure: Percutaneous cholecystostomy; Procedure: EUS-guided gallbladder drainage

Detailed Description

Acute calculous cholecystitis (ACC) is characterized by an inflammatory condition involving the gallbladder wall, most often caused by an obstruction at the infundibulum or cystic duct, with less than 10% of cases provoked by other causes.

Surgical cholecystectomy (SC), especially by laparoscopic assistance, is considered the gold standard approach for the treatment of ACC. However, some patients due to high frailty, multiple comorbidities, and clinically significant organ failure are considered suboptimal or "unfit" candidates for surgery. Therefore, less invasive approaches have been developed for this challenging population.

Percutaneous choleystostomy (PC) has been traditionally considered the first alternative in patients who are not considered for surgery, as it is a less invasive approach with lower rates of complications compared to SC. The procedure is considered technically easy for experienced interventional radiologists and is based on the insertion of a percutaneous catheter in the gallbladder under fluoroscopic assistance after an ultrasound-guided puncture with an 18-gauge needle. Nevertheless, like any other procedure, PC is not exempt from complications, such as bleeding, pneumothorax, peritonitis, injury to adjacent organs, pain at the site of insertion, catheter dislodgement, and risk for recurrent cholecystitis upon removal of the catheter.

Endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) has been described as another minimally invasive option for these patients. Under endoscopic ultrasound-guidance, a lumen-apposing metal stent is placed within the gallbladder lumen from the stomach or the duodenum (EUS-GBD), thus allowing internal drainage. EUS-GBD appears to have some benefits over PC, since the latter is typically associated with patient's discomfort and pain at the site of insertion, and carries inherent disadvantages associated with external drainage.

The management of ACC in patients who are not surgical candidates is complex. These patients carry a high risk of peri-cholecystectomy and post-cholecystectomy complications and a mortality rate of up to 19%. The initial management of patients who are not surgical candidates consists of antibiotic therapy and minimally invasive procedures for adequate gallbladder drainage. These procedures include PC and endoscopy-guided gallbladder drainage. Tokyo Guidelines-2018 (TG-18) recommend PC as the standard drainage method for surgically high-risk patients with AC. World Society of Emergency Surgery 2020 guidelines recommend considering endoscopic transpapillary gallbladder drainage (ET-GBD) or EUS-GBD as an alternative to PC in high-volume centers when performed by skilled endoscopists. There is a lumen-apposing metal stent (LAMS), which was recently approved by the Food and Drug Administration (FDA) for EUS-GBD in poor surgical candidates.

In a prior study (DRAC 1) that compared PC versus EUS-GBD in high-risk patients with ACC, EUS-GBD was associated with significantly fewer adverse events, readmissions and recurrent cholecystitis. However, the follow-up duration was only 12 months, which is a very short timeframe to reliably compare long-term outcomes between modalities. This is particularly relevant as nearly 45% of patients who do not receive a cholecystectomy die within 825 days of an attack of ACC. Also, health-related quality of life and treatment costs were not assessed in DRAC 1. Finally, the primary outcome in the DRAC 1 trial was only a single measure - adverse events. The burden of ACC and the impact of treatment is more accurately measured using a composite endpoint encompassing readmissions and reinterventions in addition to adverse events.

We hypothesize that by performing EUS-GBD as the first-line therapy in never-surgery patients presenting with ACC, the rates of procedural reinterventions, readmissions, and disease or procedure-related adverse events can be reduced as compared to patents undergoing percutaneous cholecystostomy.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara J Broome; Phone Number: 321-841-4356; Email: barbara.broome@orlandohealth.com
• Study Contact Backup: Name: Ji Young Bang, MD MPH; Phone Number: 321-842-2273; Email: jiyoung.bang@orlandohealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Digestive Health Institute
      • Contact: Barbara J Broome; Phone Number: 321-841-4356; Email: barbara.broome@orlandohealth.com
      • Contact: Ji Young Bang, MD MPH; Phone Number: 321-842-2273; Email: jiyoung.bang@orlandohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines
• Age ≥ 18 years
• Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery.
• Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement.
• Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study.

Exclusion Criteria:

• Pregnancy
• Patients who are potential candidates for future cholecystectomy.
• Patients unwilling to undergo follow-up assessments.
• Patients with suspected gangrene or perforation of the gallbladder
• Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis.
• Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
• Indwelling percutaneous cholecystostomy tube.
• Refractory/persistently significant ascites despite paracentesis.
• Distance between the gallbladder and gastric/duodenal wall that cannot be bridged by the metal stent.
• Abnormal coagulation parameters that cannot be correct: INR > 1.7 and/or platelets < 50.000/mm3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous cholecystostomy; Patients with acute calculous cholecystitis who are never-surgery candidates undergoing percutaneous cholecystostomy tube placement	Procedure: Percutaneous cholecystostomy; Percutaneous cholecystostomy tube placement by interventional radiology
Active Comparator: EUS-guided gallbladder drainage; Patients with acute calculous cholecystitis who are never-surgery candidates, undergoing EUS-guided gallbladder drainage	Procedure: EUS-guided gallbladder drainage; EUS-guided gallbladder drainage using metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events	A composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events, from index procedure to 36 months post-index intervention.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of mortality at 30 days post-index intervention due to underlying disease.	30 days
Procedure-related adverse events	Rate of procedure-related adverse events, defined as adverse events resulting from the endoscopic or radiological procedures performed. Procedure-related adverse events will be graded according to Clavien-Dindo classification.	36 months
Disease-related adverse events	Rate of disease-related adverse events, defined as adverse events resulting from underlying acute cholecystitis (such as gallbladder perforation, sepsis).	36 months
New onset single and multiple organ failure.	Rate of new onset single and multiple organ failure.	36 months
New onset systemic dysfunction.	Rate of new onset systemic dysfunction.	36 months
Intraabdominal bleeding.	Rate of intraabdominal bleeding.	36 months
Leakage of bile from the gallbladder or the biliary tract.	Rate of leakage of bile from the gallbladder or the biliary tract.	36 months
Perforation of a visceral organ requiring interventional procedure.	Rate of perforation of a visceral organ requiring interventional procedure.	36 months
Stent or percutaneous catheter-related complications	Rate of stent or percutaneous catheter-related complications, such as percutaneous catheter (cholecystostomy tube) insertion site infection, percutaneous catheter dislodgement.	36 months
Disease recurrence	Rate of disease recurrence, which includes acute cholecystitis or biliary colic.	36 months
Need for reintervention	Rate of reintervention (reintervention defined as any unplanned endoscopic, radiological or surgical intervention performed following index intervention due to recurrent or persistent symptoms or acute cholecystitis).	36 months
Total number of reinterventions performed	Total number of reinterventions performed, including endoscopic, surgical and radiological interventions.	36 months
Length of hospitalization	Length of hospitalization, including length of ICU stay.	36 months
Readmissions	Rate of readmissions due to symptoms from underlying disease or procedure-related adverse events.	36 months
New onset SIRS at 24, 48 and 72 hours, post-index intervention.	Rate of New onset SIRS at 24, 48 and 72 hours, post-index intervention.	72 hours
Resolution and improvement of SIRS at 24, 48 and 72 hours, post-index intervention.	Rate of Resolution and improvement of SIRS at 24, 48 and 72 hours, post-index intervention.	72 hours
Technical success	Rate of Technical success, defined as the successful placement of metal stent or percutaneous catheter.	36 months
Clinical success	Rate of Clinical success, defined as resolution of symptoms and normalization of laboratory parameters prior to hospital discharge after index intervention.	36 months
Health-related quality of life (HRQoL) scores	Health-related quality of life (HRQoL) scores as assessed by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) at randomization, discharge, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after index intervention.	36 months
Overall treatment costs from index intervention until hospital discharge.	Overall treatment costs from index intervention until hospital discharge. All relevant costs pertaining to treatment will be taken into consideration - procedure costs, inpatient hospital stay from date of procedure to discharge, medications, materials, anesthesia, pharmacy and imaging studies.	36 months

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Investigators: Principal Investigator: Ji Young Bang, MD MPH, Orlando Health, Digestive Health Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic ultrasound; EUS-guided gallbladder drainage; Interventional radiology; percutaneous cholecystostomy; Acute calculous cholecystitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 2440657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No