Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06311305 |
| Other study ID # |
Soh-med-24-03-07MS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
August 20, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Sohag University |
| Contact |
Abdulla M Ahmed, Master |
| Phone |
01099696698 |
| Email |
abdallah_mohamed_ex[@]med.sohag.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Gallstones have been recognised since antiquity and have been found during autopsies of
Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric
Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the
flank; and skopein, to examine) in 1985.
The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration
in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to
bile cholesterol supersaturation and nucleation.
Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis
can either be primary or secondary. Secondary Choledocholithiasis being more common occurs
due to stones originating in gallbladder and then migrating through cystic duct to CBD.
Primary bile duct stones originate from within bile ducts and are more common in Asian
populations. These stones are associated with biliary stasis and bacteria.
Description:
Gallstones have been recognised since antiquity and have been found during autopsies of
Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric
Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the
flank; and skopein, to examine) in 1985. 1 The common mechanism of gallstone formation
includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol
absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and
nucleation.2 Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2
Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being
more common occurs due to stones originating in gallbladder and then migrating through cystic
duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in
Asian populations. These stones are associated with biliary stasis and bacteria.3 The
diagnosis of choledocholithiasis is initially suggested by symptomatology, laboratory tests,
and ultrasound (US) findings. Abdominal ultrasound being the most commonly used initial
diagnostic tool for suspected biliary stones has a sensitivity of 25-60% and specificity of
95-100%.4 Ultrasound can reliably detect a dilated extrahepatic bile duct, typically a CBD >
6 mm. However, a large study of patients undergoing cholecystectomy found that nearly half of
the patients with choledocholithiasis have a nondilated CBD.5 Moreover, the diameter of the
extrahepatic bile duct increases with age and older patients may have a normal duct greater
than 6 mm. Largely, due to its poor sensitivity, a negative US does not rule out
choledocholithiasis. Contrast enhanced computed tomography has a sensitivity of 71-85% and
specificity of 88-95% which can further be improved by addition of a hepatobiliary-excreted
intravenous contrast agent.6,7 Since the introduction in 1991, Magnetic resonance
cholangiopancreatography (MRCP) has emerged as an accurate, non-invasive diagnostic modality
for investigating the biliary and pancreatic ducts with sensitivity of 90-100% and
specificity of 92-100%.8,9 An impacted biliary stone will appear as a filling defect with a
crescent of bile.10 In 1968, ERCP was introduced as a diagnostic tool in the management of
biliary and pancreatic diseases.11 With introduction of Endoscopic sphincterotomy, ERCP has
now developed as a therapeutic tool with sensitivity of 90% and specificity of 98%.12 ERCP
stone extraction is successful 80% - 90% of time using the techniques of sphincterotomy and
balloon catheter or Dormia basket stone retrieval.13 Pancreatitis is the most common
complication seen after ERCP. ERCP- induced pancreatitis is defined as new or worsened
abdominal pain with serum amylase that is greater than three times the upper limit of normal
at 24 hours post procedure and requires at least two days of hospitalisation. Although
transient elevation of pancreatic enzymes i.e. serum amylase and serum lipase are evident
after ERCP.14 Long term complications include papillary stenosis, cholangitis and recurrent
choledocholithiasis.15 The introduction of Laparoscopic cholecystectomy has significantly
influenced the treatment of patients with gallstones. Currently it is estimated that over 80%
of cholecystectomies are performed using the laparoscopic approach. Advantages of
laparoscopic cholecystectomy include earlier bowel function, less postoperative pain,
improved cosmesis, shorter length of hospital stay, earlier return to full activity and
decreased overall cost. Laparoscopic cholecystectomy (LC) preceded by preoperative ERCP
remains the cornerstone and most commonly practiced strategy worldwide for the management of
coexisting gallbladder and CBD stones.16 According to the literature, the conversion rate for
laparoscopic cholecystectomy (LC) after endoscopic sphincterotomy (ES) for
choledocholithiasis reaches 20%, when laparoscopic cholecystectomy is performed 6 to 8 weeks
afterward3. Also, many Patients waiting to undergo cholecystectomy after ES for CBD stones,
experiences recurrent biliary events requiring repeated endoscopic reintervention, emergency
cholecystectomy or both which not only have an obvious influence on a patient's well-being,
but also appear to be associated with increased difficulty of surgery and a more complicated
postoperative course.17.
Cholecystectomy is often performed after ERCP (endoscopic retrograde
cholangiopancreatography) for patients with gallstones in the common bile duct. However,
cholecystectomy after ERCP may have some risks and complications, such as:
- Longer operative time and increased bleeding
- Higher conversion rate to open cholecystectomy
- Difficulty in achieving the critical view of safety
- More post-operative drain and longer hospital stay
- Infection, perforation, pancreatitis, or bile leak. 17.18 Post ERCP cholecystectomy
assessment of difficulty is important to reduce the complications , conversion rate ,
choose of surgery team ,schedule surgery and improve outcomes .There are multiple risk
factor associated with post ERCP cholecystectomyhave beenpreviously described in the
literature such as age , sex , obesity anatomical variation ,previous surgery , impacted
stone etc .Intra operatively, it has been observed that surgeons encountered difficulty
while LC post ERCP when there were dense adhesions at calot's triangle, fibrotic and
contracted gallbladder,acutely inflamed or cholecysto-enteric fistula etc.19 The risk of
complications may depend on several factors, such as the timing of cholecystectomy after
ERCP, the presence of a stent in the bile duct, the severity of gallstone disease, and
the experience of the surgeon¹²⁴. Therefore, it is important to discuss the benefits and
risks of cholecystectomy after ERCP .20
