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CTRI Number  CTRI/2025/02/080190 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   How Stenting Improves Liver Function in Patients with Bile Duct Stones. 
Scientific Title of Study   To Evaluate the Effect of Stenting on Liver Function in Choledocholithotomy Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahid Khan 
Designation  PG Scholar 
Affiliation  Ajmal Khan Tibbiya College, Aligarh Muslim University 
Address  Department of Jarahat (Surgery), Ajmal Khan Tibbiya College and Hospital, A.M.U. Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9455019402  
Fax    
Email  shahidkhan2284@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof. Iqbal Aziz 
Designation  Professor 
Affiliation  Ajmal Khan Tibbiya College, Aligarh Muslim University 
Address  Department of Jarahat (Surgery), Ajmal Khan Tibbiya College and Hospital, A.M.U. Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897008768  
Fax    
Email  iqbalaziz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shahid Khan 
Designation  PG Scholar 
Affiliation  Ajmal Khan Tibbiya College, Aligarh Muslim University 
Address  Department of Jarahat (Surgery), Ajmal Khan Tibbiya College and Hospital, A.M.U. Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9455019402  
Fax    
Email  shahidkhan2284@gmail.com  
 
Source of Monetary or Material Support  
Department of Jarahat (Surgery), Ajmal Khan Tibbiya College and Hospital, A.M.U. Aligharh 202002 Uttar Pradesh, India 
 
Primary Sponsor  
Name  Ajmal Khan Tibbiya College, Aligarh Muslim University 
Address  Ajmal Khan Tibbiya College, Aligarh Muslim University, near Tasveer Mahal, Civil Lines, Aligarh, 202002 
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 
Shahid Khan  Ajmal Khan Tibbiya College and Hospital  Department of Jarahat (Surgery), A.M.U. Near Tasveer Mahal, Civil Lines, Aligarh 202002
Aligarh
UTTAR PRADESH 
9455019402

shahidkhan2284@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Faculty of Unani Medicine, Ajmal Khan Tibbiya College, A.M.U. Aligarh 202002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K803||Calculus of bile duct with cholangitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Liver Function Test (LFT)  Liver function tests are performed on semi-automatic or fully automated analysers, which are based on the principle of photometry. A patients blood test values should be interpreted based on the reference value of the laboratory in which the test is done. Alanine transaminase- 4 to 36 IU per L Aspartate transaminase- 5 to 30 IU per L Alkaline phosphatase- 30 to 120 IU per L Gamma-glutamyl transferase- 6-50 IU per L Bilirubin- 2 to 17 micro-mol per L Direct bilirubin- 0 to 6 micro-mol per L Prothrombin time- 10.9 to 12.5 seconds  
Intervention  Stent  Following choledochotomy, patients will receive a biliary stent (Indovasive, India) size 7 -10 Fr 10 cm straight flap into the CBD. The choledochotomy will be closed with continuous 3-0 vicryl suture across the stent. The stent will be removed 4-6 weeks after surgery through Endoscopic Retrograde Cholangiopancreatography (ERCP).  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in age group of 20 to 60 years
Patients of either gender (male/female)
Patients with hyperbilirubinaemia in the presence of gallstone disease
Patients with controlled hypertension
Presence of CBD stones in USG
Clinically examined as well as diagnosed patients of Choledocholithiasis
Patients willing to sign written consent form
 
 
ExclusionCriteria 
Details  Patients with concomitant diseases like pancreatitis, pancreatic pathology causing jaundice, renal failure, malignancy and evidence of ampullary obstruction
Patients with bile duct stenosis
Pregnant women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Liver Function Test (LFT)  60 post operative day 
 
Secondary Outcome  
Outcome  TimePoints 
CBC
RFT
Urine (Routine and Microscopy)
RBS
ECG
Chest X-ray PAV
USG (whole abdomen)
Serum amylase
Serum lipase
HbsAg
HIV 1 and 2
HCV
BT/CT
PT-INR 
60 post operative day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/02/2025 
Date of Study Completion (India) 25/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Choledocholithiasis is the 2nd most common complication of gallbladder stone disease. It affects 10-20% of individuals with symptomatic gallstones and 5% of those with asymptomatic gallstones. To prevent further issues including obstructive jaundice, pancreatitis and cholangitis, CBD stones must be removed. Choledocholithiasis treatment options include open CBD exploration, laparoscopic CBD exploration, and endoscopic retrograde cholangiopancreatography (ERCP), which may be combined with or performed after laparoscopic cholecystectomy (LC).

Choledocholithiasis is a common problem encountered approximately in 10% of asymptomatic patients during cholecystectomy. 1-2% of patients following cholecystectomy will present with a retained stone in a setting where selective cholangiography is not performed.

About 15% of people with gall bladder stone develops stone in CBD. Stones may also be found in the intra- and extrahepatic, and common bile ducts. Typically, they come from the gallbladder and travel through cystic duct. Sometimes they are formed in the ducts and are then called ‘primary duct stones’. They are common in tropics and may be due to secondary infestation of the biliary tree by Ascaris lumbricoides and Clonorchis sinesis.

The consequences of duct stones are either obstruction or infection (cholangitis).

The patient may be asymptomatic or may have symptoms of pain, jaundice and fever.

Signs: tenderness may be elicited in the epigastrium and right hypochondrium.

There are two methods for extraction of CBD stones, either by endoscopic retrograde cholangiopancreatography (ERCP) or surgically, by an open or laparoscopic method.

A good alternative to CBD decompression is the use of internal biliary stent widely used in endoscopic procedures and laparoscopic CBD exploration. Several studies have demonstrated the usefulness of these stents leading to decreased complications, morbidity and cost, as compared to t-tube in laparoscopic CBD exploration.

Prior to the use of stents, the primary treatment for biliary obstruction was surgery, such as choledochojejunostomy or choledochodudenostomy. The endoscopic placement of biliary stents was first introduced in the early 1980s. There was a rapid shift from surgery towards endoscopic retrograde cholangiopancreatography (ERCP) stent placement because of its better mortality and morbidity profile. In 1982, the first 10 French plastic stent was placed into a bile duct. In the late 1980s, self-expandable metal stents (SEMS) were adapted to the biliary tract to improve patency. In 2012, the European Society for Gastrointestinal Endoscopy (ESGE) published guidelines for clinical indications, and selection of stents. 

 
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