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For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.
At the Gastrointestinal Surgery Centre, Mansura University, Egypt, a cohort study will be conducted on a sample of 50 adult (18+) patients who undergoing ERCP. Hypotension that occurred during surgery or shortly after will be classified as exposure when it cannot be linked to a particular cause. In this study, post-ERCP sepsis will be the major outcome measure, while other ERCP-related sequelae will be the supplementary outcome measures.
Discussion:
The findings of this study will significantly advance our understanding of the potential link between intraoperative hypotension and the development of post-ERCP sepsis. This study's goal is to increase knowledge of the challenges presented by ERCP, which will aid in the creation of patient treatment methods that are more effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraoperative hypotension | The exposure is intra-operative hypotension during the ERCP procedure (hypotension is defined as a 20% reduction in the mean arterial blood pressure (MAP) or systolic arterial blood pressure (SAP) < 90 mmHg during CBD manipulation or after obstruction relief). The basal blood pressure (BP) will be the immediate reading before the endoscope insertion while the patient is in his left lateral position. |
| |
| No intraoperative hypotension | Not meeting the above definition of hypotension per our protocol (by timing, threshold, and method). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice. | Procedure | This is not an intended intervention in the study. This cohort study will study the exposure to intraoperative hypotension and the occurrence of sepsis after the ERCP procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Sepsis | Definition: SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no) | 24 hours after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital readmission | Hospital readmission (dicotomus outcome: yes or no) | 30 days after ERCP |
| Post-ERCP ICU admission | post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include 100 adult patients (≥ 18years) undergoing ERCP for obstructive jaundice at the GISC during the study period for obstructive jaundice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moataz M Emara, MD, EDAIC | Contact | +201064048848 | mm.emara@mans.edu.eg | |
| Ahmed Ali El-Din, Msc | Contact | 0201288045390 |
| Name | Affiliation | Role |
|---|---|---|
| Moataz M Emara, MD, EDAIC | Mansoura University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Univesity Faculty of Medicine | Recruiting | Al Mansurah | Aldakahlia | 35516 | Egypt |
The anonymized patient data will be available with the principal investigator and can be shared on reasonable request after approval of the IRB.
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within 2 years after publication
with contact with the principal investigator with reasonable request and approval of the local IRB.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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|
| 7 days after ERCP |
| Length of hospital stay | in days (continuous outcome) | 30 days after ERCP |
| Postoperative bacteremia | Bactermia on blood culture (post-ERCP in comparison to the pre-ERCP blood culture): (dicotomus outcome: yes or no) | 24 hours after surgery |
| Post-ERCP pancreatitis | Raised lipases and amylase (dicotomus outcome: yes or no) | 24 hours after ERCP |
| Post-ERCP RBCs transfusion | any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no) | 24 hours after ERCP |
| 30-day all-cause mortality | Death of any cause (dicotomus outcome: yes or no) | 30 days after ERCP |
| Delayed post-ERCP Sepsis | SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no) | 7 days after ERCP procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |