Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Gallbladder Drainage, Percutaneous Gallbladder Drainage.
- Who it may be relevant to
- Registry conditions: Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety Evaluation of Endoscopic Treatment for Benign Gallbladder Diseases: A Multicenter Prospective Cohort Study
Overview
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.
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.
Interventions
- Procedure Endoscopic Gallbladder Drainage
Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal. - Procedure Percutaneous Gallbladder Drainage
Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.
Primary outcome measures
- Incidence of Overall Adverse Events [Time frame: Up to 1 year after the initial drainage procedure]
Secondary outcome measures (11)
- Rate of technical success for EUS-GBD [Time frame: During the procedure]
- Rate of technical success for PT-GBD [Time frame: During the procedure]
- Rate of technical success for ETGBD [Time frame: During the procedure]
- Clinical success [Time frame: Within 3 days (72 hours) postoperatively]
- Unplanned re-interventions within 1 year postoperatively [Time frame: At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively]
- Early adverse events [Time frame: 14 days postoperatively]
- Late adverse events [Time frame: 30 days, 90 days, 6 months, and 1 year postoperatively]
- Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score [Time frame: 6 months postoperatively, and 1 year postoperatively]
- Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score [Time frame: 6 months postoperatively, and 1 year postoperatively]
- Total length of hospital stay [Time frame: From date of admission through date of discharge, up to 30 day]
- Total cost of hospitalization [Time frame: Through discharge, up to 30 days]
Eligibility criteria
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:
- High-risk surgical patients: ASA classification ≥ III, or presence of severe comorbidities that significantly increase the risk of laparoscopic cholecystectomy (LC);
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xijing Hospital of Digestive Diseases — Xi'an
Identifiers
NCT: NCT07649811 · XJLL-KY-20262123