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This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis.
The main problem we aim to solve is that inflammation in the bile duct wall often makes standard ICG doses ineffective for clear visualization. We will use pre-operative MRI to measure the thickness of the common bile duct (CBD) wall, then calculate a personalized ICG dose using a simple formula. We will first test and refine this formula in a small group of patients, then verify its effectiveness in a second group. The goal is to achieve clear, high-contrast imaging of the bile ducts, which helps surgeons operate more safely and accurately.
All patients will receive a low, personalized dose of ICG given by vein 1 hour before surgery. We will evaluate how well the bile ducts show up on the fluorescence images, as well as safety and effectiveness outcomes. This study will provide a practical, patient-tailored solution for improving bile duct visualization in emergency gallbladder surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized ICG Fluorescence Cholangiography Arm | Experimental | All patients with moderate to severe acute cholecystitis undergoing emergency laparoscopic cholecystectomy receive an individualized, low-dose indocyanine green (ICG) injection. The ICG dose is calculated using a formula based on preoperative MRI-measured common bile duct wall thickness (0.012 + 0.0035625 × wall thickness, mg/kg), administered intravenously 1 hour before surgery. Near-infrared fluorescence cholangiography is performed during surgery to visualize the biliary anatomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) Fluorescence Cholangiography | Drug | Indocyanine green (ICG) is administered intravenously 1 hour before emergency laparoscopic cholecystectomy. The dose is individualized based on preoperative MRI-measured common bile duct wall thickness using the formula: 0.012 + 0.0035625 × wall thickness (mg/kg). Near-infrared fluorescence cholangiography is performed intraoperatively to visualize the biliary anatomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Biliary Tract Visualization Quality Score | Intraoperative assessment of biliary tract visualization quality using a 4-point subjective scale (1=poor, 2=fair, 3=good, 4=excellent). The score is assigned by the operating surgeon based on the clarity of the cystic duct and common bile duct fluorescence signals, with a primary endpoint of achieving a mean score of ≥3.0 across all enrolled patients. | Intraoperatively (during emergency laparoscopic cholecystectomy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39901108 | Background | Li T, Lin C, Wang W. Global, regional, and national burden of pancreatic cancer from 1990 to 2021, its attributable risk factors, and projections to 2050: a systematic analysis of the global burden of disease study 2021. BMC Cancer. 2025 Feb 3;25(1):189. doi: 10.1186/s12885-025-13597-z. | |
| 41653278 | Background |
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|
| Li T, Zhao Y, Dong L, Han J, Zhao B, Lin C, Wang W. Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery. J Robot Surg. 2026 Feb 7;20(1):227. doi: 10.1007/s11701-026-03176-0. |
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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