The reason for this method of Cholangiography is that: Cystic Duct Cannulation can be difficult!
Procedure Videos
The Kumar Cholangiography®
Device Description
The Kumar Clamp® is a 5 mm laparoscopic grasper with
- Long atraumatic jaws and
- A channel for introduction of
- The Kumar Catheter® that carries a 1.25 cm long 19 ga needle to puncture the Hartmann’s Pouch of the gallbladder for easy biliary access and Cholangiography
The Kumar Cholangiography® Method
- The Kumar Clamp®(KC-002) is applied through the right mid-subcostal port (the Kumar Clamp, KC-2XL, is applied through the single port) and is used as a regular grasper for traction at the infundibulum during cystic duct dissection. The channel valve at the upper end is closed to maintain pneumoperitoneum.
- When the dissection is complete, the cystic duct is milked towards the gallbladder. This enhances cystic duct patency.
- The Kumar Clamp® is then reapplied all the way across the neck of the gallbladder—just above the Hartmann's pouch (Fig. 2) above.
- This catheter is different because it has a 1.25 cm long, 19 gauge needle at the end. The catheter is advanced so that the needle punctures the Hartmann's pouch of the gallbladder in a bull's-eye manner. The Clamp can be tilted or rotated to center the needle.
- Caution: The catheter fits snugly into the channel to prevent CO₂ leaks. Do not try to close the channel valve while the catheter is in the channel. This can cut or damage the catheter.
- As the Hartmann's pouch is punctured, bile is aspirated to confirm biliary access. Bile flashback is clearly seen through the clear catheter. Dye is injected for a quick and easy Cholangiography!
- The Aspiration Advantage - After cholangiography is done, the Clamp jaws are opened, and the gallbladder is aspirated. This makes it much easier to separate the gallbladder from the liver bed and extract it from the port site.
- When the catheter is removed, the channel valve can be closed—or left open as a smoke vent!
- The Grasping Gadget - The clamp can again be used as a grasper to finish the operation, usually grasping the gallbladder at the needle puncture site. This assures no bile leakage from the needle puncture site, although the gallbladder has already been aspirated and is empty.
CYSTIC DUCT OBSTRUCTION
Cystic duct obstruction can occur with or without hydrops (acute cholecystitis):
- In the absence of Hydrops:
This happens when the cystic duct is partially obstructed by mucus, sludge, or a tiny stone. The maneuvers of cystic duct dissection and milking of the cystic duct towards the gallbladder will help dislodge the small stone, sludge, or mucous. This will allow cystic duct patency and flow of dye for cholangiography. - When there is hydrops (or acute cholecystitis):
This happens when the cystic duct is completely obstructed by a stone that is impacted at the neck of the gallbladder. The gallbladder is distended and cannot even be grasped.
This is also called a hot gallbladder. The following method is recommended:
- The gallbladder is pushed up with an open grasper through the right lateral port. The jaws of the grasper are kept open since the gallbladder cannot be grasped.
- The Kumar Clamp® is applied through the right mid-subcostal port. The jaws of the Kumar Clamp® are also kept open for the same reason. (Fig. 3). The Kumar Clamp® is moved as low as possible on the body of the gallbladder.
- If exposure is not satisfactory, it may be necessary to insert a fan-shaped retractor (through an additional port).
- The Kumar Catheter® is then introduced, and the gallbladder is punctured and aspirated at a point as low as possible on the body of the gallbladder.
This relieves the pressure that was pushing the stone into the neck of the gallbladder.
In fact, a negative pressure has been created behind the stone, physiologically. The stone should fall back into the gallbladder.
- The decompressed gallbladder can now be grasped.
- The stone can additionally be manipulated with a grasper through the midline port and dislodged.
- Dye is injected for cholangiography, preferably through the same access that was used for aspiration. At times, it is necessary to move the clamp and the catheter needle to a lower level on the gallbladder.
Aspiration of Hydrops with Open Clamp Jaws
- The decompressed gallbladder can now be grasped.
- The stone can additionally be manipulated with a grasper through the midline port and dislodged.
- Dye is injected for cholangiography, preferably through the same access that was used for aspiration. At times, it is necessary to move the clamp and the catheter needle to a lower level on the gallbladder.
WHAT YOU WILL LOVE
1. Versatility
Applied through the right mid-subcostal port, the Kumar Clamp® is used as a
- Regular Grasper during dissection of the cystic duct and removal of the gallbladder from the liver bed, as well as a
- Cholangiography Clamp.
No need to introduce and remove different instruments for different parts of the same operation.
2. No Cystic Ductotomy
Injury of the common bile duct due to mistaken ductotomy of the common bile duct
(Type I injury) is eliminated!
3. No Cystic Duct Cannulation: the “pain is gone!”
4. Safety
- No ducts are clipped or divided until the biliary anatomy is previewed.
- By moving the clamp back and forth during fluoroscopy, you can “uncoil” the cystic duct and evaluate its length.
- You will be forewarned of the “short” cystic duct.
5. The Aspiration Advantage!
After cholangiography, please note that a 19 ga. needle is located in the dependent portion of the gallbladder. Clamp jaws can be opened, and the gallbladder is aspirated. This greatly facilitates the separation of the gallbladder from the liver bed and extraction from the port site.
6. O.R. Time and Cost Savings
- Cholangiography is performed in minutes.
- Gallbladder aspiration allows easy removal of the gallbladder from the liver bed
- Extraction through the site is also quick because the gallbladder has been aspirated already
WARNINGS AND PRECAUTIONS
- Avoid injury to the lower surface of the liver from the tips of the Clamp jaws.
- Always operate the instruments under direct laparoscopic monitoring.
LOOSE PARTS ADVISORY
There are three (3) loose or removable parts on the Kumar Clamp® and the Kumar SILS Clamp® each: the black plastic cap over the flush port, the channel valve assembly, and the screw that holds the valve in place.
None of these enter the body during normal use. Caution is necessary when the operation is converted to open surgery.
HOW SUPPLIED
The Kumar Clamp® (KC-002) is a reusable 5 mm grasper of 37 cm length. It is supplied non-sterile. The Kumar Clamp (KC-2XL) is a reusable 5 mm grasper for single-port, bariatric, and robotic procedures and is 45 cm in length. See Instructions for Sterilization below.
The Kumar Catheter® is 76 cm long and 16 ga. with a 19 ga., 1.25 cm long needle. It is supplied sterile and is for single-patient use only. Discard properly after use. DO NOT RESTERILIZE OR REUSE.
STERILIZATION
The Kumar Clamp®(KC-002) and The Kumar(KC-2XL) Clamp(used for single port, bariatric, and robotics): Clean and steam autoclave in accordance with the guidelines of the Association for the Advancement of Medical Instruments (AAMI): Standards and Recommended Practices. Sterilization in Healthcare Facilities. CLEAN AND STERILIZE AFTER EACH USE. See Detailed Instructions below.
The Kumar Catheter® is supplied sterile and is for single-patient use only.
Sterility is guaranteed unless the package is opened or damaged.
DO NOT RESTERILIZE.
CAUTION: Do NOT close or tighten the Channel
Valve when the Catheter is in the channel.
This can damage the catheter.
CAUTION: Federal (USA) law restricts this device to use by or on the order of a physician.
Manufactured for:
Nashville Surgical Instruments
2005 Kumar Lane
Springfield, TN 37172 USA
INSTRUCTIONS FOR CLEANING & STERILIZATION
Kumar Clamp® - Kumar SILS Clamp
Preparation
Inspect the instrument after each use for damaged or loose parts and proper function. Remove any gross contamination. To assure cleaning of all surfaces, the clamp jaws, channel valve, and flush-port cap must be open.
- An initial cold water and blood/protein-dissolving enzyme solution rinse (or soak for heavy contamination) helps remove blood, tissue, and debris from device lumens, joints, and serrations.
- Flush and clean the interior of the instrument through the flush port and the catheter channel (Fig. 1) with cold water, blood/protein-dissolving enzyme, and antiseptic solution. Allow the solution to contact for 5 minutes.
- Pre-clean clamp jaws and tips with a brush.
- Place the instrument in a separate wire basket on the top shelf of the automated washer/decontaminator and allow a full cycle run.
- Allow the instrument to air dry in the basket. Then remove & inspect for any residual contamination.
- Allow the residue of rinse water to remain in instrument channels. This allows steam to form during the sterilization process. If needed, inject distilled or deionized water into channels.
Follow institutional policy and procedures. Wrap properly for steam sterilization with a sterilization indicator strip in the lowest and most inaccessible portion of the packaging. Use two layers of non-woven disposable sterilization wrap on the outside of the packaging. Seal with sterilization indicator tape. Label, initial, and date.
- Follow the sterilizer manufacturer's instructions for use of the steam sterilizer.
- Recommended Minimum Exposure Times (Minutes after conditioning) for Steam Sterilization: Gravity 250 F (121c): 30 minutes. Gravity 270 -274 F (132 -134 c): 15 minutes; pre-vac 270 -274 F (132 - 134 c): 4 minutes.
- Remove from the sterilizer and allow cooling on the sterilizer rack. Assure package integrity and store on designated shelves for sterile instruments.
- Inspect the instrument closely before each use for damage, loose parts, and proper function.
Bibliography
The Kumar Cholangiography®
Scientific Publications
- The Koala Trial NTR2582: 2011
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2582 Nieuwenhuijs, Vicent: Kumar versus Olsen Clamp for
Laparoscopic Cholangiography
- Asian Journal of Endoscopic Surgery 2: 3, A-93; 2009
Kumar, SS: Prevention of Common Bile Duct Injury by Cystic Duct Marking: A New Paradigm
- Proceedings of the 11th World Congress of Endoscopic Surgery: Sept 2-5, 2008: Yokohama, Japan 2008
Kumar, S. S.: Prevention of Common Bile Duct Injury by Cystic Duct Marking.
- Journal of American College of Surgeons 204: 725; 2007
Kumar SS: An Alternative to Cystic Duct Marking during Intraoperative Cholangiography.
- Current Problems in Surgery, 35:10, 901-2, 1998
Lobe,T.E.: Laparoscopic Surgery in Children.
- Seminars in Laparoscopic Surgery,5:1, 2-8, 1998 Holcomb, G. W.: Laparoscopic Cholecystectomy.
- Pediatric Endoscopic Surgery, 159-67, 1995. Appleton & Lange, Publishers, Norwalk, CT Holcomb, G. W.: Laparoscopic Cholecystectomy.
- Surgical Endoscopy, 8:8, 927-30,1994 Holzman, M.D.; Sharp, K.; Holcomb, G. W.; Frexes-Steed, M.; Richards, W. O.: An Alternative Technique
for Laparoscopic Cholangiography.
- General Surgery and Laparoscopy News, Sept. 1993:
New Laparoscopic Clamp Eases Cholangiography.
- Journal of Laparoendoscopic Surgery, 2:5,247-54,1992
Kumar, S. S.: Laparoscopic Cholangiography: a New Method and Device.
Frequently Asked Questions
Is there leakage of bile around the needle during injection of dye?
Since no incision (such as a ductotomy) has been made and biliary access has been obtained by only a needle puncture, there is no leakage of dye around the needle unless there is Cystic Duct Obstruction. See number 5 below.
Is there leakage of bile from the needle hole after the needle is removed?
Since the gallbladder has been emptied by aspiration after cholangiography, bile leakage is only a small droplet, just as upon cystic ductotomy.
Can the needle go through the back wall of the Hartmann’s pouch?
No. The needle length is only 1.25 cm, and the angle of entry of the needle does not point towards the back wall of the Hartmann’s pouch.
If a stone is located in the Hartmann’s pouch, can it be pushed by the needle or washed by the dye into the common bile duct? The Washable Stone?
This problem has not occurred in clinical practice in over hundreds of thousands of cholangiograms that have been performed with this method.
Three factors prevent the passage of a stone into the common bile duct during injection of dye into the Hartmann’s Pouch:
- The valves of Heister in the cystic duct.
- The cystic duct is tortuous and not a straight, rigid conduit.
- The radiographic dye is slick and easily flows around the stones.
In addition, we know that a tiny stone in the cystic duct can be pushed into the common bile duct during conventional cystic duct cannulation also. Experience has shown that these are not of clinical significance and pass uneventfully.
How can this method work if there is cystic duct obstruction?
Cystic duct obstruction can occur with or without Hydrops. It is managed by the methods described above. Please see details above.