The Kumar Cholangiography® Method

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1. 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 pneumo-peritoneum.
   
   
2. When the dissection is complete, the cystic duct is milked towards the gallbladder. This enhances cystic duct patency.
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3. The Kumar Clamp® is then re-applied all the way across the neck of the gallbladder--- just above the Hartmann's pouch (Fig. 2)
   
   
4. The channel valve at the upper end of the Clamp is opened and the Kumar Catheter® (CC-019) is introduced in to the Clamp channel. 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.                               
   
5. Caution: The Catheter fits snug into the Channel to prevent CO2 leak. Do NOT try to close the Channel Valve while Catheter is in the     Channel. This can cut or damage the Catheter.
   
6. 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!
   
   
7. 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 portsite.
   
   
8. When the Catheter is removed, the Channel valve can be closed—or left open as a smoke vent!
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9. 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.

​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 cystic duct and during 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 portsite.

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 portsite is also quick because the gallbladder has been aspirated already

 
WARNINGS AND PRECAUTIONS

1. Avoid injury to the lower surface of the liver from the tips of the Clamp jaws.
2. 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 5mm grasper for Single Port, Bariatrics and Robotics and is 45 cm length. See Instructions for Sterilization below.

The Kumar Catheter® is 76 cm long, 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, Bariatrics and Robotics): Clean and steam autoclave in accordance with the guidelines of Association for 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.

             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

INSTRUCTIONS FOR CLEANING & STERILIZATION

Kumar Clamp® - Kumar SILS Clamp

Preparation
Inspect 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 the flush-port cap must be open.

Pre-Rinse

1. 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 & serrations.
   
   
2. Flush and clean interior of instrument through the Flush Port and the Catheter Channel (Fig. 1) with cold water and blood/protein-dissolving enzyme and antiseptic solution. Allow solution contact for 5 minutes.
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3. Pre-clean clamp jaws and tips with a brush.

Washing / Decontamination

1. Place instrument in a separate wire basket on top shelf of the automated washer / decontaminator and allow a full cycle run.
   
   
2. Allow instrument to air dry in basket. Then remove & inspect for any residual contamination.
   
   
3. Allow residue of rinse water to remain in instrument channels. This allows steam to form during the sterilization process. If needed, inject distilled or de-ionized water in to channels.    

Packaging
Follow institutional Policy and Procedures. Wrap properly for steam sterilization with sterilization indicator strip in lowest and most inaccessible portion of the packaging. Use two layers of non-woven disposable sterilization wrap on outside of packaging. Seal with sterilization indicator tape. Label and initial and date.

Sterilization

1. Follow sterilizer manufacturer instructions for use of the steam sterilizer.
   
   
2. 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.
   
   
3. Remove from sterilizer and allow to cool on sterilizer rack. Assure package integrity and store on designated shelves for sterile instruments.
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4. Inspect instrument closely before each use for damaged, loose parts and proper function.
   

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

• 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.
  

Caution: The Catheter fits snug into the Channel to prevent CO2 leak. Do NOT try to close the Channel Valve while Catheter is in the Channel. This can cut or damage the Catheter.

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 mucous, 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.
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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 in to the neck of the gallbladder.
In fact, a negative pressure has been created behind the stone, physiologically. The stone should fall back in to 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.
  

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The Reason for this method of Cholangiography is that Cystic Duct Cannulation can be difficult!

We Make Two Things Easier  

Nashville Surgical Instruments

Aspiration of Hydrops with Open Clamp Jaws

Sterility is guaranteed unless package is opened or damaged.
DO NOT RESTERILIZE.
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CAUTION: Do NOT close or tighten the Channel
Valve when Catheter is in the channel.
This can damage the catheter.

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 in to 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:

1. The valves of Heister in the cystic duct.

2. The cystic duct is tortuous and not a straight, rigid conduit.
3. 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 in to 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.

​Bibliography

The Kumar Cholangiography®
Scientific Publications

1. The Koala Trial NTR2582: 2011
   http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2582 Nieuwenhuijs, Vicent: Kumar versus Olsen Clamp for
   Laparoscopic Cholangiography
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2. 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
   
   
3. 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.
   
   
4. Journal of American College of Surgeons 204: 725; 2007
   Kumar SS: An Alternative to Cystic Duct Marking during Intraoperative Cholangiography.
   
   
5. Current Problems in Surgery, 35:10, 901-2, 1998 
   Lobe,T.E.: Laparoscopic Surgery in Children.
   
   
6. Seminars in Laparoscopic Surgery,5:1, 2-8, 1998 Holcomb, G. W.: Laparoscopic Cholecystectomy. 
   
   
7. Pediatric Endoscopic Surgery, 159-67, 1995. Appleton & Lange, Publishers, Norwalk, CT Holcomb, G. W.: Laparoscopic Cholecystectomy. 
   
   
8. 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. 
   
   
9. General Surgery and Laparoscopy News, Sept. 1993: 
   New Laparoscopic Clamp Eases Cholangiography.
   
   
10. Journal of Laparoendoscopic Surgery, 2:5,247-54,1992 
    ​Kumar, S. S.: Laparoscopic Cholangiography: a New Method and Device.