To assess whether cholangiography using the Kumar clamp is faster and easier than using the Olsen catheter.
ID
Source
Brief title
Condition
- Gallbladder disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the time necessary for IOC, defined as the
time from insertion of the instrument for cystic ductotomy (control arm) or the
Kumar clamp (intervention arm) to the time that the x-ray arm is rolled out of
the operative field.
Secondary outcome
The secondary endpoint is the surgeon's judgement of the ease of the procedure
(measured by questionnaire).
Background summary
Laparoscopic cholecystectomy (LC) is the most commonly performed operation in
abdominal surgery. A dreaded complication of the procedure is bile duct injury
(BDI), which is associated with occasional mortality, often major morbidity,
high costs and decreased long-term quality of life. Intraoperative
cholangiography (IOC) has been shown to decrease the risk of BDI by 33 to 50%.
It also doubles the proportion of BDI detected in an early stage and allows
intraoperative detection of common bile duct stones. Although the IOC is part
of standard procedure in the UMCG, there is resistance to the routine
application of IOC in the Netherlands and other parts of the world. Reasons for
this resistance include the sometimes cumbersome procedure of dissecting the
cystic duct to insert the cholangiography catheter, and the extra operation
time needed. Another disadvantage of the conventional technique is that it is
only applicable once the cystic duct has been positively identified, which is
in a relatively late phase of the procedure.
An alternative instrument for IOC is the Kumar clamp. This clamp was first
described in 1992 but after one promising initial review has not been reported
upon in the medical literature. The instrument consists of a clamp which is
placed over the base of the gallbladder and an attached needle which extends
into the gallbladder into Hartmann*s pouch. The radiopaque contrast is then
injected through the needle. The advantages of the instrument is that it does
not require identification or dissection of the cystic duct. It can be applied
in an earlier phase of the operation and may well decrease the time necessary
for cholangiography.
Study objective
To assess whether cholangiography using the Kumar clamp is faster and easier
than using the Olsen catheter.
Study design
A double blind (patient and investigator) two-armed randomized controlled
trial.
Intervention
Patients in both arms of the study will undergo laparoscopic cholecystectomy
using the standard critical view of safety technique. Patients in the control
arm will undergo IOC in the standard manner using a cystic duct catheter.
Patients in the intervention arm will undergo IOC using the Kumar clamp. If
this technique fails to provide a satisfactory cholangiogram, conventional IOC
will also take place.
Study burden and risks
The burden associated with participation is the use of an instrument that has
not been previously used in the UMCG. However, it has been in use since 1995
and no extra risk has been reported resulting from its use. It is FDA approved,
CE Mark and ISO Certified. Surgeons using the clamp will receive training in
its use in the skills laboratorium from an abdominal surgeon with extensive
experience with cholangiography.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Patients aged 18-70 with an indication for laparoscopic cholecystectomy with intraoperative cholangiography.
Exclusion criteria
Malignancies of the gallbladder.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30638.042.09 |