info.3se@keehealthcare.com

Percutaneous Nephrolithotomy (PCNL)

“Percutaneous nephrolithotomy, or PCNL, is a procedure for removing medium-sized or larger renal calculi (kidney stones) from the patient’s urinary tract by means of an nephroscope passed into the kidney through a track created in the patient’s back. The term “”percutaneous”” means that the procedure is done through the skin. Nephrolithotomy is a term formed from two Greek words that mean “”kidney”” and “”removing stones by cutting.”” Purpose The purpose of PCNL is the removal of renal calculi in order to relieve pain, bleeding into or obstruction of the urinary tract, and/or urinary tract infections resulting from blockages. Kidney stones range in size from microscopic groups of crystals to objects as large as golf balls. Most calculi, however, pass through the urinary tract without causing problems. Renal calculi are formed when the urine becomes supersaturated (overloaded) with mineral compounds that can form stones. This supersaturation may occur because the patient has low urinary output, is excreting too much salt, or has very acid urine. Urolithiasis is the medical term for the formation of kidney stones; the word is also sometimes used to refer to disease conditions associated with kidney stones. There are several different types of kidney stones, in terms of chemical composition: Calcium oxalate calculi. About 80% of calculi found in patients in the United States are formed from calcium combined with oxalate, which is a salt formed from oxalic acid. Some foods, such as rhubarb and spinach, are high in oxalic acid. Oxalic acid is also formed in the body when vitamin C is broken down. Oxalic acid is ordinarily excreted through the urine but may be absorbed in large amounts due to chronic pancreatic disease or surgery involving the small intestine. Uric acid calculi. These stones develop from crystals of uric acid that form in highly acidic urine. Uric acid calculi account for about 5% of kidney stones. In addition, some kidney stones are a combination of calcium oxalate and uric acid crystals. Cystine calculi. Cystine calculi represent about 2% of kidney stones. Cystine is an amino acid found in proteins that may form hexagonal crystals in the urine when it is excreted in excessive amounts. Kidney stones made of cystine indicate that the patient has cystinuria, a hereditary condition in which the kidneys do not reabsorb this amino acid. Struvite calculi. Struvite is a hard crystalline form of magnesium aluminum phosphate. Kidney stones made of this substance are formed in patients with urinary tract infections caused by certain types of bacteria. Struvite calculi are also known as infection calculi for this reason. Staghorn calculi. Staghorn calculi are large branched calculi composed of struvite. They are often discussed separately because their size and shape complicate their removal from the urinary tract. Some people are more likely than others to develop renal calculi. Risk factors for kidney stones include: Male sex. Family history. Having a first-degree relative with urolithiasis increases a person’s risk of developing kidney stones. Age over 30. Diet. People whose diet is high in protein or who eat foods rich in oxalate are more likely to develop kidney stones. Dehydration. People who do not drink enough fluid each day to replace what is lost through perspiration and excretion produce very concentrated urine. It is easier for crystals to form in concentrated than in dilute urine, and to grow into kidney stones. Metabolic disorders affecting the body’s excretion of salt or its absorption of calcium or oxalate. Most cases of urolithiasis in children are related to metabolic disorders. Intestinal bypass surgery and ostomies. People who have had these surgical procedures lose larger than average amounts of water from the digestive tract. Description Standard PCNL A standard percutaneous nephrolithotomy is performed under general anesthesia and usually takes about three to four hours to complete. After the patient has been anesthetized, the surgeon makes a small incision, about 0.5 in (1.3 cm) in length in the patient’s back on the side overlying the affected kidney. The surgeon then creates a track from the skin surface into the kidney and enlarges the track using a series of Teflon dilators or bougies. A sheath is passed over the last dilator to hold the track open. After the track has been enlarged, the surgeon inserts a nephroscope, which is an instrument with a fiberoptic light source and two additional channels for viewing the inside of the kidney and irrigating (washing out) the area. The surgeon may use a device with a basket on the end to grasp and remove smaller kidney stones directly. Larger stones are broken up with an ultrasonic or electrohydraulic probe, or a holmium laser lithotriptor. The holmium laser has the advantage of being usable on all types of calculi. A catheter is placed to drain the urinary system through the bladder and a nephrostomy tube is placed in the incision in the back to carry fluid from the kidney into a drainage bag. The catheter is removed after 24 hours. The nephrostomy tube is usually removed while the patient is still in the hospital but may be left in after the patient is discharged. Mini-percutaneous nephrolithotomy A newer form of PCNL is called mini-percutaneous nephrolithotomy (MPCNL) because it is performed with a miniaturized nephroscope. MPCNL has been found to be 99% effective in removing calculi between 0.4 and 1 in (1 and 2.5 cm) in size. Although it cannot be used for larger kidney stones, MPCNL has the advantage of fewer complications, a shorter operating time (about one and a half hours), and a shorter recovery time for the patient. During the Procedure After the Procedure Risks Diagnosis Kidney stones may be discovered during a routine x ray study of the patient’s abdomen. These stones, which would ordinarily pass through the urinary tract unnoticed, are sometimes referred to as silent stones. In most cases, however, the patient seeks medical help for sudden intense pain in the lower back, usually on the side of the affected kidney. The pain is caused by the movement of the stone in the urinary tract as it irritates the tissues or blocks the passage of urine. If the stone moves further downward into the ureter (the tube that carries urine from the kidney to the bladder), pain may spread to the abdomen and groin area. The patient may also have nausea and vomiting, blood in the urine, pain on urination, or a need to urinate frequently. If the stone is associated with a UTI, the patient may also have chills and fever. The doctor will order both laboratory studies and imaging tests in order to rule out such other possible causes of the patient’s symptoms as appendicitis, pancreatitis, peptic ulcer, and dissecting aneurysm. The imaging studies most commonly performed are x ray and ultrasound. Pure uric acid and cystine calculi, however, do not show up well on a standard x ray, so the doctor may also order an intravenous pyelogram, or IVP. In an IVP, the radiologist injects a radioactive contrast material into a vein in the patient’s arm, and records its passage through the urinary system in a series of x ray images. Blood and urine samples will be taken to test for indications of a urinary tract infection. If the patient passes the kidney stone, it is saved and sent to a laboratory for analysis. Preparation Most hospitals require patients to have the following tests before a PCNL: a complete physical examination ; complete blood count ; an electrocardiogram (EKG); a comprehensive set of metabolic tests; a urine test; and tests that measure the speed of blood clotting. Aspirin and arthritis medications should be discontinued seven to 10 days before a PCNL because they thin the blood and affect clotting time. Some surgeons ask patients to take a laxative the day before surgery to minimize the risk of constipation during the first few days of recovery. The patient is asked to drink only clear fluids (chicken or beef broth, clear fruit juices, or water) for 24 hours prior to surgery, with nothing by mouth after midnight before the procedure.”

How it works?

1.

Request for medicine

Patient who has serious problem request for medicine

 

2.

Drug Verify

Internal processing of drug verifications at GM Global

 

3.

Prescription

Recognizing best source for the specific prescription

 

4.

GDP Instruction

Import medicine under the GDP instruction

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

FAQ

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

 

No. Companies are not required to provide their products through a formal NPP.

 

  • Dealing with unsolicited patient request for drug in an ethical and regulatory controlled manner
  • Providing exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
  • Providing new products to patients who would move to commercial drug when it becomes available in these countries
  • Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

 
 

INFORMATION FOR PATIENTS

As a named patient medicines you may find yourself in the frightening position that you have a serious condition or illness and the treatment you need is not available in your home country. It is possible that the medicines are available outside your country and if your physician decides that these drugs would be suitable for the treatment of your illness, they then face the challenge of obtaining them for you. We help physicians across the world access medicines which are not approved or licensed in their country, but may be required to meet the special needs of an individual patient. The service we provide not only locates and supplies the required medicines but ensures that the physician has all the quality assurance and supporting clinical information they will need to safely prescribe it to you. If you are confronted with a situation where a drug is not available to you, talk to your physician or healthcare professional about Named Patient Program and ask them to contact us. We will then work directly with your physician to help them in patient access program and understand what options are available.

 

 

Drugs We Provide Under NPS

Drug Directory

Orphan Drugs

1.

Request for medicine

Patient who has serious problem request for medicine

 

2.

Drug Verify

Internal processing of drug verifications at GM Global

 

3.

Prescription

Recognizing best source for the specific prescription

 

4.

GDP Instruction

Import medicine under the GDP instruction

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

FAQ

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

 

No. Companies are not required to provide their products through a formal NPP.

 

  • Dealing with unsolicited patient request for drug in an ethical and regulatory controlled manner
  • Providing exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
  • Providing new products to patients who would move to commercial drug when it becomes available in these countries
  • Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

 
 

INFORMATION FOR PATIENTS

As a named patient medicines you may find yourself in the frightening position that you have a serious condition or illness and the treatment you need is not available in your home country. It is possible that the medicines are available outside your country and if your physician decides that these drugs would be suitable for the treatment of your illness, they then face the challenge of obtaining them for you. We help physicians across the world access medicines which are not approved or licensed in their country, but may be required to meet the special needs of an individual patient. The service we provide not only locates and supplies the required medicines but ensures that the physician has all the quality assurance and supporting clinical information they will need to safely prescribe it to you. If you are confronted with a situation where a drug is not available to you, talk to your physician or healthcare professional about Named Patient Program and ask them to contact us. We will then work directly with your physician to help them in patient access program and understand what options are available.