Clinical trial NCT06239233: Gallbladder Infundibulum as a Guide for Ductal Identification.
Official title: Gallbladder Infundibulum as a Guide for Ductal Identification in Laparoscopic Cholecystectomy in Nepalese Population at Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gallstone Disease
Lead sponsor: Nepal Mediciti Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic cholecystectomy at Nepal Mediciti Hospital.

Brief summary: Introduction: Bile duct injury (BDI) is a catastrophic complication of cholecystectomy, and misidentification of the cystic anatomy is considered to be the main cause. Although several techniques have been developed to prevent BDI, such as the "critical view of safety", the infundibular technique, the rates remain higher during laparoscopic cholecystectomy (LC) than during open surgery. Strategy for ductal identification during laparoscopic cholecystectomy can help to prevent laparoscopic bile duct injury.

Methods: A prospective study of 196 patients who will undergo LC during the study period of one year at Nepal Mediciti Hospital will be conducted. The gallbladder infundibulum will be classified by its position located on an imaginary clock with the gallbladder neck as the center point of the dial, 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral, as well as the axial position. Patient demographics, pathologic variables and infundibulum classification will be evaluated. Detailed analysis of ductal identification based on gallbladder infundibulum position will be performed in this study. All infundibulum positions will be recorded during intraoperative laparoscopic procedure.

Detailed description: 1. Objectives:

General Objective:

To investigate the potential association between infundibulum orientation and cystic duct identification during laparoscopic cholecystectomy.

Specific Objective:

1. To assess the influence of different infundibulum orientations on the success rate and time taken for cystic duct identification.
2. To evaluate the incidence and risk factors associated with post-operative morbidities following laparoscopic cholecystectomy.

Age, Sex, Ethnicity, Religion, Clinical Diagnosis, Intra operative gall bladder infundibulum orientation, relation of cystic duct with infundibulum, post operative complications. Success of cystic duct identification, duration of surgery, intraoperative blood loss and conversion to open are dependent variables and Position of infundibulum demographic, preoperative laboratory parameters, ultrasonographic findings are independent variables.

2. Ethical Considerations:

Ethical clearance was taken from National Health research council. Patient confidentiality and privacy will be maintained throughout the data collection and analysis process.

3. Data Collection:

Data will be collected on a structured Proforma covering the relevant subject matter of the study. A detailed orientation of the study and enrollment systems will be given to all doctor colleagues and ward in-charge for admitted patients. Upon receiving a case fulfilling the inclusion criteria, he/she will be given adequate explanation about the disease process, procedures performed and about the study. He/she will be assured of full confidentiality and would be asked if he/she wants to enroll in the study or not and an informed written consent taken subsequently. A detailed clinical history, clinical examination with appropriate investigations will be carried out. Demographic data will be collected including age, sex, and occupation. The relevant investigation including complete blood count, urine routine, blood sugar, blood urea, serum creatinine, serum electrolyte s, liver function test, chest X-ray including both dome of diaphragm, ECG ultrasonography of abdomen and pelvis etc. will be done as required for diagnosis. After establishing the diagnosis informed consent will be obtained. All patients diagnosed with gall stone disease will undergo laparoscopic cholecystectomy using three ports which will be performed under general anesthesia. First 10-millimeter port will be placed in infraumbilical region using open technique. Pneumoperitoneum will be created using carbon dioxide up to pressure of 12mm of Hg. Another 10-millimeter port will be placed in epigastrium below xiphoid process. Final 5-millimeter port will be placed in right hypochondrium. Adhesiolysis will be done if necessary. Visceral peritoneum over gall bladder infundibulum will be removed and Hartmann's pouch will be looked for.

Classification of the gallbladder infundibulum: The gallbladder infundibulum is variable in size and shape, and when this funnel-shaped portion is eccentrically inflated, it is called a Hartmann's pouch. According to our experience, this pouch lies at different directions with respect to the cystic duct and the common bile duct with a certain regularity. As the patient is placed in a supine position, and the surgeon stands on the left side of the patient with a line-of-sight from left to right, an imaginary clock facing the surgeon is vertically placed with the gallbladder neck as the center point of the dial. The Hartmann's pouch is assigned a location on this imaginary clock face to distinguish its positions (with the 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral). In addition, if the infundibulum portion is uniformly dilated without a Hartmann's pouch, the investigators refer to this condition as axial position.

Furthermore, if the infundibulum with axial position is obviously inflated, it is defined as type I, otherwise, it is defined as type II(1). All the positions of the infundibulum will be identified during the laparoscopic process. Whether the Hartmann's pouch guide the investigator in finding the cystic duct will be noted. The time of surgery, blood loss, need for additional port placement and conversion to open will be noted.

4. Inclusion and Exclusion Criteria:

Inclusion criteria:

All the patient undergoing laparoscopic cholecystectomy for gall stone disease above age 18years.

Exclusion criteria:

Patients undergoing Laparoscopic cholecystectomy for Carcinoma Gallbladder. 5. Patient Consent:

Informed consent from patients for inclusion in the registry will be obtained, ensuring that they understand the purpose of the registry and the use of their data for research.

6. Data Quality and Validation:

Reliability of the study tool will be ensured by involving multiple observers and coming to an agreeable conclusion and as mentioned in methodology a complete standardized instructions about the tool will be employed. Validity of the study tool will be maintained by pilot testing and taking adequate sample to represent the population.

7. Statistical Analysis: Data management and analysis will be done in Excel and IBM SPSS 20. Tables, pie charts and bar diagrams will be used to demonstrate the results. Mean age (in years), Frequency and percentage of different sex, religion, occupation, co-morbidities, high total leukocyte count, abnormal renal function test, liver function test, will be calculated. Frequency and percentage of different position of infundibulum, success of cystic duct identification, conversion to open cholecystectomy will be calculated. Mean intraoperative blood loss (in milliliters), duration of operation time (in minutes), length of hospital stay (in hours) will be calculated. Frequency and percentage of post operative complications will be calculated. Logistic regression will be used to see any potential association between infundibulum orientation and success of cystic duct identification.

10. Dissemination: The results will be published in a peer reviewed journal.

Eligibility criteria: Inclusion Criteria:

* All the patient undergoing laparoscopic cholecystectomy for gall stone disease above age 18years.

Exclusion Criteria:

* Patients undergoing Laparoscopic cholecystectomy for Carcinoma Gallbladder.

Primary outcomes:
measure: The investigator will identify the position of the Hartmann's pouch if present as 12,3,6 and 9 o' clock position. If the Hartmann's pouch is absent, then it will be labelled as axial type. Collected data will be aggregated in percentage.
timeFrame: 1 year.
Secondary outcomes:
measure: Incidence and risk factors associated with post-operative morbidities.
timeFrame: [Time Frame: 1 year]
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Nepal Mediciti Hospital
state: Central
Study officials:
affiliation: Nepal Mediciti Hospital
name: Rajiv Mishra, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shang P, Liu B, Li X, Miao J, Lv R, Guo W. A practical new strategy to prevent bile duct injury during laparoscopic cholecystectomy. A single-center experience with 5539 cases. Acta Cir Bras. 2020;35(6):e202000607. doi: 10.1590/s0102-865020200060000007. Epub 2020 Jul 8.