Gallbladder DiseasesGB-PRESERVENCT07649811
Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation
An observational study of Gallbladder Diseases and Cholecystitis, Acute, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis
- What is being tested?
- Endoscopic Gallbladder Drainage and Percutaneous Gallbladder Drainage
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710000
Yanglin Pan, +86 13991811225, yanglinpan@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis
- Being tested
- Endoscopic Gallbladder Drainage, Percutaneous Gallbladder Drainage
- Keywords
- EUS-GBD, ET-GBD, PT-GBD, Gallbladder Preservation, High Surgical Risk, Endoscopic Drainage
- Medical subject headings
- Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Gallbladder DrainageProcedure or surgery
Also called EUS-GBD, ET-GBD
Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.
Percutaneous Gallbladder DrainageProcedure or surgery
Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Treatment Group | Not described Receives: Procedure: Endoscopic Gallbladder Drainage | |
| Non-endoscopic Treatment Group | Not described Receives: Procedure: Percutaneous Gallbladder Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year after the initial drainage procedure
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively
Early adverse events
Measured: 14 days postoperatively
Late adverse events
Measured: 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.
Measured: 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.
Measured: 6 months postoperatively, and 1 year postoperatively
Total length of hospital stay
Measured: From date of admission through date of discharge, up to 30 day
Total cost of hospitalization
Measured: Through discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649811
- Sponsor's protocol ID
- XJLL-KY-20262123
- Acronym
- GB-PRESERVE
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Endoscopic Treatment for Benign Gallbladder Diseases: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07649811
- Acronym / sponsor ID
- GB-PRESERVE / XJLL-KY-20262123
- Conditions
- Gallbladder Diseases, Cholecystitis, Acute, Cholelithiasis
- Keywords
- EUS-GBD, ET-GBD, PT-GBD, Gallbladder Preservation, High Surgical Risk, Endoscopic Drainage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Treatment Group | – | Procedure: Endoscopic Gallbladder Drainage |
| Non-endoscopic Treatment Group | – | Procedure: Percutaneous Gallbladder Drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Gallbladder DrainageAlso: EUS-GBD, ET-GBDMinimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal. | Procedure or surgery | Endoscopic Treatment Group |
| Percutaneous Gallbladder DrainageTraditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage. | Procedure or surgery | Non-endoscopic Treatment Group |
Primary outcome
Incidence of Overall Adverse Events
Time frame: Up to 1 year after the initial drainage procedure
Adverse events related to the drainage procedure and subsequent treatments, including but not limited to bleeding, infection, bile leak, pancreatitis, and stent-related complications.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Diseases and Cholecystitis, Acute, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan (+86 13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Overall Adverse Events (time frame: Up to 1 year after the initial drainage procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.