CTRI

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CTRI Number

CTRI/2024/08/071843 [Registered on: 02/08/2024] Trial Registered Prospectively

Last Modified On:

31/07/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Single Arm Study

Public Title of Study

Injecting Methylene blue into the gall bladder for delineation of bile duct during laparoscopic cholecystectomy

Scientific Title of Study

Intraoperative injection of Methylene blue into the gall bladder for delineation of Extrahepatic biliary tree during Laparoscopic Cholecystectomy

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Varadheswari Thiagarajan
Designation	Postgraduate
Affiliation	Government Stanley Medical College and Hospital
Address	Department of General Surgery, Government Stanley Medical College and Hospital, Old Jail Road, Royapuram, Chennai Chennai TAMIL NADU 600001 India
Phone	09600407488
Fax
Email	easwari1994@gmail.com

Details of Contact Person
Scientific Query

Name	Vivekanand C
Designation	Assistant Professor
Affiliation	Government Stanley Medical College and Hospital
Address	Department of General Surgery, Government Stanley Medical College and Hospital, Old jail road, Royapuram, Chennai Chennai TAMIL NADU 600001 India
Phone	09600407488
Fax
Email	drvivek83@yahoo.co.in

Details of Contact Person
Public Query

Name	Varadheswari Thiagarajan
Designation	Postgraduate
Affiliation	Government Stanley Medical College and Hospital
Address	Department of General Surgery, Government Stanley Medical College and Hospital, Old Jail Road, Royapuram, Chennai TAMIL NADU 600001 India
Phone	09600407488
Fax
Email	easwari1994@gmail.com

Source of Monetary or Material Support

Department of General Surgery, Government Stanley Medical College and Hospital, Old jail road, washermanpet, Chennai, Tamil nadu, India - 600001

Primary Sponsor

Name	Government Stanley Medical College and Hospital
Address	Department of General Surgery, Government Stanley Medical College and Hospital, Old jail road, washermanpet, Chennai, Tamil nadu, India - 600001
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Varadheswari	Government Stanley Medical College and Hospital	Department of General Surgery, Government Stanley Medical College and Hospital, Old jail road, Royapuram, Chennai - 600001 Chennai TAMIL NADU	9600407488 easwari1994@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	1. To utilize methylene blue as an agent to study the delineation of extrahepatic biliary anatomy.	In an upcoming laparoscopic cholecystectomy, once adhesions are carefully released from the gall bladder fundus, it will be securely grasped and gently drawn towards the anterior abdominal wall using two atraumatic graspers introduced via trocars in the right anterior axillary and subxiphoid regions. A Veress needle will then be employed to puncture the gall bladder fundus, introduced via the abdominal wall in alignment with this specific area. The entire content of bile within the gall bladder will be aspirated, followed by the gradual injection of a 50 percent dilution of methylene blue (methylene blue available in elective theatre as diluted aqueous form post sterilisation), equivalent to the aspirated bile volume, into the gall bladder (considering the typical gallbladder capacity ranges from 30 to 50 ml, the maximum amount of methylene blue injected will be approximately 15 to 25 ml). To prevent potential leakage of methylene blue, the gall bladder fundus will be consistently held taut internally during the withdrawal of the Veress needle. A grasper introduced via the right lateral trocar will be promptly applied to the puncture site and retained throughout the operation, alternatively, the puncture site will be secured with a clip. The designated area will undergo thorough irrigation with saline solution. Throughout the cholecystectomy procedure, clear visualization and delineation of the gall bladder, cystic duct, and common bile duct will be facilitated by the presence of the methylene blue dye, enhancing the safety of the dissection. To further mitigate the risk of methylene blue leakage, an endo-bag will be utilized to extract the gall bladder. Subsequently, a closed suction drain will be positioned in the right subhepatic space and brought out through the right lateral trocar. All the cases will be operated by the same surgeon to avoid variability of operating room time.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Patients aged between 20 and 65 will be included in this study. Patients with diagnosis of symptomatic cholelithiasis and chronic cholecystitis confirmed by preoperative abdominal ultrasound. Patients scheduled for elective laparoscopic cholecystectomy. Patients who are willing and give consent for this procedure.

ExclusionCriteria

Details

Previous history of biliary surgery.
Previous history of malignancy involving the biliary tract.
Associated pancreatitis or hepatitis or jaundice.
Presence of contraindications to laparoscopic cholecystectomy.
Known allergy to methylene blue.
Not willing to provide informed consent.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
o Number of cases in which anatomical variations in cystic duct noted o Number of cases in which anatomical variations in common bile duct noted o Number of cases in which injury to bile duct detected o Number of cases in which bile leak/ spillage of dye noted o Mean time taken for surgery o Duration of hospital stay	During surgery - over 1 hour the above variables are measured. Duration of hospital stay calculated from the time of surgery to the time of discharge

Secondary Outcome

Outcome	TimePoints
Number of cases in which anatomical variations in cystic duct noted Number of cases in which anatomical variations in common bile duct noted Number of cases in which injury to bile duct detected Number of cases in which bile leak/ spillage of dye noted	Mean time taken for surgery Duration of hospital stay

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

15/08/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The study will include patients admitted in surgical units at Government Stanley Medical College and Hospital scheduled for elective laparoscopic cholecystectomy with preoperative indication of symptomatic cholelithiasis and chronic cholecystitis.