An observational study in Gallbladder Diseases, Cholecystitis, Acute and Cholelithiasis, sponsored by Air Force Military Medical University, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Air Force Military Medical University, China · Observational
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.
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.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 220 is close to the median of 216 across 52 observational studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
Compared within Cholecystitis, Acute, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gallbladder Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Endoscopic Gallbladder Drainage
Procedure: Percutaneous Gallbladder Drainage
Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.
Also known as: EUS-GBD, ET-GBD
Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.
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.
Time frame: Up to 1 year after the initial drainage procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
Of 22 observational studies under Cholecystitis, Acute, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China →