Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation (GB-PRESERVE)

Efficacy and Safety Evaluation of Endoscopic Treatment for Benign Gallbladder Diseases: A Multicenter Prospective Cohort Study

Common gallbladder conditions like gallstones, polyps, and gallbladder inflammation are typically treated by surgically removing the gallbladder. However, surgery may be too risky for elderly patients or those with severe medical conditions, and some patients strongly prefer to keep their gallbladder.

Newer, less-invasive endoscopic treatments can drain the gallbladder to treat inflammation without surgery. However, after successful drainage, doctors currently do not know whether it is better to leave a stent inside for long-term drainage or to actively remove the gallbladder stones using an endoscope.

This multicenter study will follow patients in a real-world setting to compare these two approaches: the endoscopic treatment group (stone removal after drainage) and the non-endoscopic treatment group (long-term drainage alone). The goal is to evaluate which method is safer and more effective over the long term, helping doctors make better clinical decisions and improve patients' quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis, Acute; Gallbladder Diseases; Cholelithiasis
• Intervention / Treatment: Procedure: Endoscopic Gallbladder Drainage; Procedure: Percutaneous Gallbladder Drainage

Detailed Description

Benign gallbladder diseases, such as symptomatic cholelithiasis, gallbladder polyps, and acute cholecystitis, are common in clinical practice. Although laparoscopic cholecystectomy (LC) remains the gold standard treatment, its application is limited in elderly patients, individuals with severe comorbidities, or specific populations who strongly desire to preserve gallbladder function (termed "high-risk" or specific-preference patients).

In recent years, endoscopic gallbladder drainage techniques characterized by ultra-minimally invasive approaches-such as endoscopic transpapillary gallbladder drainage (ET-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)-have advanced rapidly. These techniques not only provide a critical, life-saving means for patients unable to undergo surgery during the acute phase, but also elevate the therapeutic goal from simple "drainage for inflammation control" to a new height of "long-term disease management" and "organ function preservation." However, following successful drainage, whether to opt for long-term passive drainage via indwelling stents or to actively pursue endoscopic stone removal for a potential "cure" currently lacks guidance from high-level clinical evidence.

Therefore, conducting a large-scale, multicenter, prospective cohort study to evaluate and compare endoscopic treatments for gallbladder diseases holds significant theoretical and practical value. First, at the clinical practice level, this prospective study aims to systematically compare the long-term efficacy and safety between the "endoscopic treatment group" (elective transoral stone removal after drainage) and the "non-endoscopic treatment group" (long-term passive drainage alone). This will provide direct evidence to resolve the core clinical conflict between "gallbladder preservation" and "disease recurrence," driving the treatment paradigm shift from a technical capability-oriented approach to a precise patient benefit-oriented one. Second, at the academic level, this study will be the first to clarify the impact of endoscopic interventions on patients' long-term gallbladder function, quality of life, and subsequent clinical pathways within a large-scale cohort, thereby filling a critical evidence gap in this field. Finally, at the health policy level, the study findings will provide a core foundation for establishing individualized and standardized clinical guidelines, optimizing medical resource allocation, and ultimately improving the overall prognosis and quality of life for patients with complex gallbladder diseases.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Yanglin Pan; Phone Number: +86 13991811225; Email: yanglinpan@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xijing Hospital of Digestive Diseases
      • Contact: Yanglin Pan; Phone Number: +86 13991811225; Email: yanglinpan@hotmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

high-risk acute cholecystitis patients ineligible for surgery, or patients with benign gallbladder diseases who have a strong preference and clinical requirement for gallbladder-preserving therapy

Description

Inclusion Criteria:

• Age ≥ 18 years, and voluntarily signed the informed consent form;

• Radiologically confirmed symptomatic benign gallbladder disease (symptomatic gallbladder stones, gallbladder polyps meeting surgical indications, acute cholecystitis TG18 Grade I/II); and meeting any of the following specific population criteria:

  1. High-risk surgical patients: ASA classification ≥ III, or presence of severe comorbidities that significantly increase the risk of laparoscopic cholecystectomy (LC);
  2. Patients with concomitant common bile duct stones (CBDS) and a strong desire for gallbladder preservation: presence of CBDS confirmed by MRCP/ERCP examination, and still strongly requesting the preservation of gallbladder function after being fully informed.

Exclusion Criteria:

• Suspected or confirmed gallbladder malignancy;
• Complications requiring emergency surgical intervention (gangrene, perforation, diffuse peritonitis);
• Uncorrectable severe coagulation dysfunction;
• Presence of severe anatomical deformity or obstruction of the stomach, duodenum, or esophagus, where the endoscope is expected to be unable to reach the target site (papilla or pericholecystic area);
• Significant gallbladder atrophy (longitudinal diameter < 4 cm or anteroposterior diameter < 2 cm);
• Pregnant or lactating women;
• Previous history of cholecystectomy;
• Presence of psychiatric disorders or any condition that prevents cooperation with treatment and follow-up;
• Unwilling or unable to sign the informed consent form.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Treatment Group	Procedure: Endoscopic Gallbladder Drainage; Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.; Other Names: EUS-GBD; ET-GBD
Non-endoscopic Treatment Group	Procedure: Percutaneous Gallbladder Drainage; Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Overall Adverse Events	Adverse events related to the drainage procedure and subsequent treatments, including but not limited to bleeding, infection, bile leak, pancreatitis, and stent-related complications.	Up to 1 year after the initial drainage procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of technical success for EUS-GBD	The percentage of participants who achieve successful endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). Technical success is defined as successful placement of a lumen-apposing metal stent (LAMS) in the gallbladder, achieving effective gallbladder drainage via a transmural approach.	During the procedure
Rate of technical success for PT-GBD	The percentage of participants who achieve successful percutaneous transhepatic gallbladder drainage (PT-GBD). Technical success is defined as successful placement and establishment of an effective external drainage.	During the procedure
Rate of technical success for ETGBD	The percentage of participants who achieve successful endoscopic transpapillary gallbladder drainage (ETGBD). Technical success is defined as successful crossing of the anatomical barriers of the papilla and the cystic duct, and successful placement of an endoscopic nasogallbladder drainage (ENGBD) tube or an endoscopic gallbladder stent (EGBS) within the gallbladder.	During the procedure
Clinical success	Clinical success is defined as symptom resolution within 3 days (72 hours) after surgery, characterized by defervescence and improved abdominal pain, along with improvement in inflammatory markers including a white blood cell count of < 10 × 10^9/L and a continuous downward trend in C-reactive protein (CRP) levels synchronous with clinical improvement.	Within 3 days (72 hours) postoperatively
Unplanned re-interventions within 1 year postoperatively	Through postoperative inpatient observation and post-discharge telephone follow-ups, the investigators will monitor and record whether patients require any additional, unplanned secondary invasive procedures (including endoscopic therapy, interventional radiologic puncture, or surgery) following successful initial gallbladder drainage (such as EUS-GBD, PT-GBD/PTGBD, or ETGBD) or surgical treatment, resulting from unexpected clinical deterioration, drainage device malfunction/failure, or treatment-related complications.	At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively
Early adverse events		14 days postoperatively
Late adverse events		30 days, 90 days, 6 months, and 1 year postoperatively
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score	The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score ranges from values below 0 (health states worse than death) to 1.0 (perfect health). Higher scores indicate better health-related quality of life.	6 months postoperatively, and 1 year postoperatively
Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score	The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire assessing gastrointestinal symptoms, physical status, emotional status, social function, and treatment effects. Total scores range from 0 to 144, with higher scores indicating better gastrointestinal quality of life.	6 months postoperatively, and 1 year postoperatively
Total length of hospital stay		From date of admission through date of discharge, up to 30 day
Total cost of hospitalization		Through discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: High Surgical Risk; Endoscopic Drainage; PT-GBD; EUS-GBD; ET-GBD; Gallbladder Preservation
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Cholecystitis; Gallbladder Diseases; Cholecystitis, Acute; Cholelithiasis
• Other Study ID Numbers: XJLL-KY-20262123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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