Preparing Laparoscopic Cholecystectomy Cases

By Robert A. Zielke

For years, physicians have successfully used laparoscopic techniques. Surgical instruments - microscissors, lasers, and electrocautery devices - are inserted and manipulated through incisions in the patient’s abdomen and monitored on a video display terminal. Initially used for exploratory gynecological procedures, laparoscopic surgery has recently been applied in other surgical contexts. In 1989, the first cases of laparoscopic surgery for gallbladder disease were reported in the United States. Since then, laparoscopic cholecystectomy, rather than the traditional open procedure, has become popular for removing the gallbladder. However, many surgeons have not been adequately trained to perform laparoscopic cholecystectomies, resulting in injuries to patients and giving rise to a new medical negligence claim.

This article will describe the basic medical procedure, highlight a recent case that the author successfully tried, and offer attorneys strategies for evaluating and preparing these cases.

The Procedure

A surgeon inflates a patient’s abdomen with carbon dioxide to create a safety space for placing trocars - sharp metal rods - into the abdomen. Gas fills the area between the bowel and the abdominal wall. The surgeon inserts a trocar blindly into the patient’s abdomen through a small incision by the umbilicus (belly button). The trocar is removed, leaving a hollow sheath - portals used for inserting and removing instruments and the laparoscopic camera - that enters into the abdomen. Sheaths have gas seals that prevent the carbon dioxide from escaping. The surgeon then inserts the camera through the umbilical sheath. Three other trocars with sheaths are inserted while the surgeon watches each one enter the abdomen on the video display terminal.

Next, the surgeon exposes the gallbladder. The physician then dissects tissue to identify and expose the cystic artery, which supplies the gallbladder with blood, and the cystic duct, which connects the gallbladder to the common bile duct.

The surgeon then places surgical clips to occlude the cystic artery and the cystic duct. Intraoperative cholangiography (IOC) is then performed. The surgeon makes a small cut into the cystic duct and inserts a tube. Dye is injected through the catheter into the biliary tree, filling the biliary system from the intestine up into the liver. Once the dye is injected, an X-ray is taken and read by the surgeon and, occasionally, by a radiologist before continuing with the operation. The IOC is significant because it (1) confirms the location and course of the biliary anatomy, (2) allows the surgeon to identify anatomical variations or abnormal anatomy before cutting the structures believed to be the cystic artery and the cystic duct, (3) reveals gallstones that may be in the bile ductal system, and (4) serves as a check for any iatrogenic injury, such as clipping the wrong structure.

Often, the dye does not fill the upper biliary system but flows towards and empties into the bowel. This can occur absent negligence. The surgeon should repeat the procedure, placing the patient in a slightly head down position and injecting a larger volume of dye. Sometimes, a gallstone will block the upward flow of dye and must be removed. If multiple attempts to fill the biliary system fail, the surgeon must consider converting to the traditional open procedure.

Finally, the surgeon transects the cystic artery and the cystic duct, freeing the gallbladder except for its attachment to the liver bed. Using electrocautery - an arc of electric current - or laser energy, the surgeon then dissects the gallbladder from the liver bed. Once detached, the gall-bladder is removed through the umbilical sheath. The surgical instruments and laparoscopic camera are removed, the carbon dioxide is released from the abdomen, and the sheaths are removed. The surgeon closes the small skin incisions with sutures, and the patient is taken to the recovery room.

The Holum Case

On July 9, 1990, Jacqueline Holum, 28, was admitted to a hospital for a laparoscopic cholecystectomy. Martin, the surgeon, dissected out and identified the cystic artery and cystic duct. Surgical clips were placed across these structures. Martin then performed an IOC, which was abnormal in that (1) the biliary system above the junction of the cystic duct with the common bile duct never filled with dye and (2) there was a sharp bend in the common duct, indicating tenting - traction that pulls the bile duct from its normal course. Tenting is a surgeon’s warning flag. It changes the relationship of the cystic duct and the common hepatic duct, making it more likely that the surgeon will clip or cut the common hepatic duct rather than the cystic duct.

After reviewing the abnormal IOC, Martin did not repeat the procedure but used electrocautery to detach the gallbladder from the liver bed. Each time he turned on the electrocautery, electrical interference was produced on the video screen display. Martin modified his cautery-dissecting technique by changing from a sweeping motion to a stab-and-fire motion. (He later dictated in Holum’s operative report that the electrical interference made the dissection of the gallbladder very difficult.)

Before dissecting the gallbladder free, Martin cut into a liver-bed blood vessel with the cautery. The vessel began to bleed, and Martin tried to control this by applying pressure and electrocautery to the area. He then converted to the traditional open procedure to control the bleeding vessel. Laparoscopic equipment was removed, and the incision for a trocar and sheath was enlarged. He placed a suture into the area to control the bleeding. The gallbladder was removed, and Martin examined the surgical area before closing the incision. He identified no injury to the biliary system.

Seven days later, Holum was readmitted to the hospital’s emergency room and a CT scan showed a large amount of bile in her abdomen. Martin chose to perform another operation to control the bile leak. He sutured an area of the liver where he thought bile was leaking and placed two drains in her abdomen to remove the bile. Holum’s bile leak continued for several weeks, flowing into collecting bags outside her body.

Martin then consulted a gastroenterologist. X-rays revealed a severe stricture of the common hepatic duct, as well as a bile leak from the same area.

Holum has no assurances that her biliary system will continue to function and not re-stricture in the future. If this occurs, she will require a hepaticojejunostomy - a procedure to remove the damaged bile duct and connect normal bile duct from the above the stricture to the bowel, which is surgically brought up to the liver - to maintain bile flow into the bowel.

Holum retained the author and Thomas R. Golden, both of the Seattle, Washington, firm Sullivan & Golden, to represent her in a suit against Martin. Plaintiff alleged Martin had been negligent in (1) placing surgical clips on the common hepatic duct rather than exclusively on the cystic artery, (2) applying electrocautery energy directly onto the common hepatic duct, (3) exclusively dissecting the tissues containing the blood vessels supplying blood to the common hepatic duct, and (4) failing to convert to an open procedure when he could not control the bleeding liver vessel and electrical interference appeared on the video screen display. Plaintiffs also claimed that had the abnormal IOC been repeated and the biliary system filled with dye up into the liver, Martin would or should have seen clips on the bile duct. Plaintiff’s experts provided testimony that had the clips been removed, it was probably that no permanent ductal injury would have occurred.

The Holum case went to trial, and the jury awarded plaintiff $250,000.00. Holum v. Mt. Rainier Surgical Assoc., Wash., Pierce County Super. Ct. No. 91-3-10757-8, Jan. 4, 1993.

Trial Strategies

In evaluating and trying a case, counsel must investigate the following issues -

• The physiologic basis and nature of plaintiff’s injury. This requires a thorough understanding of the biliary anatomy as well as the stages of a laparoscopic cholecystectomy. Surgical companies produce instructional videos about the procedure. Generally, these can be obtained from the plaintiff’s expert witnesses.

Injuries include bile duct injury; trocar puncture injuries to the bowel, other organs, and major vessels; bleeding or bile leakage from the liver bed after dissection of the gallbladder; and burns to various organs from electrocautery or lasers. Some injuries, such as a bile leak from the liver bed caused by deep dissection, occur absent negligence; others rarely do. For example, a complete transection of the common hepatic duct generally occurs because a surgeon misidentified the anatomy.

We argued that Holum’s injury - a severe stricture of the common hepatic duct - was caused by Martin’s negligence. To prove this, we obtained the X-rays from the gastroenterologist Martin had consulted. At trial, plaintiff’s surgical expert testified that the X-rays showed Martin had been negligent in (1) misidentifying the biliary anatomy and placing surgical clips on the common hepatic duct rather than on the cystic artery and (2) cauterizing the duct. Plaintiff’s diagnostic radiologist explained that the X-rays showed the clips on the duct.

• The surgeon’s training, experience, and qualifications. Most surgeons have not been trained in laparoscopic techniques during their surgical residencies but learn them in two- to three-day seminars. Proof that a defendant learned the technique at a seminar, combined with his or her actual limited experience with the procedure, can be powerful in persuading a jury regarding negligence.

The printed course materials and videotapes from the seminars may also prove helpful. For example, after reviewing materials from Martin’s one-day seminar we found that Martin had been trained to use a laser, not electrocautery, to perform laparoscopic cholecystectomies. We pointed out to the jury that Martin had negligently used electrocautery during Holum’s surgery because he had not been properly trained to use it for the procedure.

Attorneys should be aware that most injuries that may result from a laparoscopic cholecystectomy are likely to occur during a surgeon’s learning curve - the first 13 to 25 patients. One study found that the incidence of bile duct injuries in the first 13 patients operated on by 10 surgical groups was 2.2 percent, compared with 0.1 percent for later patients. See The Southern Surgeons Club, A Prospective Analysis of 1518 Laparoscopic Cholecystectomies, 324 New Eng.J. Med. 1073 (1993). Counsel should attempt to have the surgeon and both sides’ experts agree that an injury such as plaintiff’s generally occurs during the learning curve. In Holum, we cited the article after discovering that plaintiff fell within Martin’s learning curve - she was Martin’s eleventh laparoscopic cholecystectomy patient.

In investigating qualifications, counsel should request the following from the hospital where a surgeon works; (1) its credentialing requirements for surgeons performing laparoscopic cholecystectomies; (2) the surgeon’s application for laparoscopic-surgery privileges, which specifies his or her experience; and (3) the surgeon’s operative reports of patients who have had the surgery. Counsel should determine if defendant met the Society of American Gastrointestinal Endoscopic Surgeons’ recommendations on credentialing requirements for surgeons performing laparoscopic cholecystectomies. In Holum, we discovered that the hospital where Martin worked required only that surgeons wishing to perform the procedure show proof of having attended a laparoscopic cholecystectomy course.

The surgeon’s prior injury history for open and laparoscopic gallbladder surgeries should be examined. We obtained Martin’s previous laparoscopic operative reports. The report on Holum indicated the video monitor interference Martin had encountered when performing the procedure had been produced by cautery. No other report discussed cautery interference. We argued that Martin cauterized the common hepatic duct because the interference did not allow him to use the monitor to perform the procedure.

• Technical difficulties - monitor interference, fogging of the laparoscope or camera, or malfunctioning laparoscopic equipment. These can be used to show the surgeon failed to timely convert to a traditional gallbladder operation. Most surgeons advise their patients that if they encounter these difficulties, they will perform an open procedure. Surgical experts can testify at trial as to whether the laparoscopic cholecystectomy should have been converted to an open procedure.

• The surgeon’s techniques. Many laparoscopic cholecystectomies are videotaped. If plaintiff’s surgery was videotaped, counsel should obtain the tape to evaluate what techniques the surgeon used and whether he or she properly identified the biliary anatomy. If a videotape is not available, counsel can introduce to the jury a video showing each stage of the procedure. Plaintiff’s experts can then explain what techniques would have produced the particular injury. This is what we did in Holum.

• Informed consent. Counsel must determine whether the surgeon told plaintiff the risks of a laparoscopic cholecystectomy. The plaintiff’s experts can address the material risks of the procedure. In Holum, defendant told plaintiff that traditional gallbladder surgery and laparoscopic cholecystectomies carry the same risks. He also told her that if he encountered difficulties during the procedure he would convert to an open procedure. We contended defendant had failed to timely convert to traditional open surgery.

• Hospital liability. The major area for hospital negligence occurs when hospitals negligently grant surgeons privileges to perform the procedure. Counsel should explore the hospital’s credentialing requirements. The date of the plaintiff’s injury is important in evaluating this issue. In early cases, some hospitals were requiring only a letter or certificate of completion of a course before granting privileges. Many hospitals later added the requirement of about five proctored cases before privileges could be granted. This was not an issue in Holum.

Laparoscopic cholecystectomy is a relatively new phenomenon in the surgical community. People who have sustained serious injuries during these procedures can prevail in medical negligence actions. To provide the best opportunity for success, counsel must understand the basics of the procedure and the type of injury involved and must conduct an in-depth investigation into the surgeon’s training, qualifications, and experience.

Zielke, 8 Professional Negligence Law Reporter 132 − September 1993