| 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
|
|
|
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
|
|
|
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. |