Transumbilical flexible endoscopic cholecystectomy in humans: first feasibility study using a hybrid technique

• Introduction
• Patients and methods
• Procedure
• Results
• Discussion
• References

Background: Natural-orifice transluminal endoscopic surgery (NOTES) procedures have been tested using numerous approaches, mainly in animals. In humans, only cholecystectomy has been assessed, using a combined transvaginal and transumbilical approach. We present another variant of a hybrid technique for cholecystectomy, namely the combination of a flexible transumbilical double-channel endoscope and a 3-mm rigid transcutaneous trocar placed in the left hypochondrium for liver retraction.

Patients and methods: The procedure was attempted in 10 well-selected young patients (M : F = 4 : 6, mean age 29.5 years). Instruments used through the two working channels of the endoscope were either a grasping forceps or snare for grasping and pulling and a hot-biopsy forceps for cold and hot preparation and dissection. Endoclips were used for cystic duct and artery closure. Postoperative analgesia consisted of one intravenous dose of analgesic, followed by oral administration for one further day. Follow-up visits were scheduled at 7 days, 30 days, 90 days, and 6 months.

Results: In 4 of the 10 cases the operation had to be converted to conventional laparoscopic cholecystectomy due to difficulty in dissection (in 2 cases) or uncontrollable hemorrhage (2 cases). The mean operating time was 148 minutes. Of the 6 cases in which the procedure was finished by the new approach, cystic artery bleeding occurred in 1 and was successfully clipped. One further patient had a postoperative cystic duct leak with a bilioma, successfully treated by endoscopic retrograde cholangiopancreatography with stenting. Five of the six patients reported themselves as satisfied at 3- or 6-month follow-up.

Conclusions: So far, our endoscope-based transumbilical cholecystectomy technique has not yielded satisfactory results in humans. Further instrument and accessory improvements may increase both success rate and acceptance. Scarless surgery without the inherent risks of a transluminal approach may then become feasible.

Introduction

Natural-orifice transluminal endoscopic surgery (NOTES) is the newest trend in the field of surgery. Several techniques have been described, mainly in animals, that utilize various natural orifices - for example, transgastric, transvaginal, transvesical, and transcolonic approaches - but none of these is currently well standardized [1] [2] [3] [4] [5]. Techniques that involve the combination of transluminal and laparoscopic (mainly transumbilical) access have been used for the first cholecystectomies reported in humans [5] [6] [7] [8] [9]. On the other hand, Zhu has described the transumbilical approach as the main access route to the abdominal cavity in general [10]. Here, the umbilicus serves as a ”natural scar” by which to attain abdominal access. In the present series, we describe our experiences in human patients with transumbilical flexible endoscopic cholecystectomy supported by a small additional transcutaneous port.

Patients and methods

A prospective study was carried out between January and November 2007 designed to include 10 well-selected patients with symptomatic cholelithiasis who would be treated with the new technique of transumbilical endoscopic cholecystectomy. Patients with complicated disease (mass, abscess), liver cirrhosis, peritonitis, known adhesions, upper abdominal scars, or obesity, or who were high-risk patients for general anesthesia were excluded. Patients had explained to them the details, advantages, and risks including conversion to the laparoscopic (or even pen) technique as well as the differences between this approach and laparoscopy. Informed consent was obtained and the study was approved by the hospital’s ethics committee. Prior to starting in humans, the technique had been developed and practiced in a total of 35 pigs and other animal models during the preceding year. The initial complication rate of 32 % dropped to 18 %, with a success rate rising from an initial 34 % to a later 72 %.

Preoperative workup included blood and urine investigations, abdominal ultrasonography, chest radiography, and CT scan. Prophylactic intravenous antibiotics were administered 1 hour prior to the operation in all cases (and one dose postoperatively). Oral liquid nutrition was commenced 12 - 24 hours following surgery, and a soft diet from the 1st postoperative day onward. Only one dose of parenteral analgesics (NSAIDs) was administered in all cases, followed by oral analgesics for one further day.

Procedure

The patients were placed in the supine position. The entire team stood on the left side of the patient with the monitor placed on the directly opposite side of the patient. Under general anesthesia, a Veress needle was introduced at the umbilicus via a 2-mm stab and pneumoperitoneum was created. Then, a 3-mm trocar was introduced for a 3-mm laparoscope in the umbilicus to assess the feasibility of the endoscopic procedure. Once the procedure was deemed feasible, the 3-mm trocar was replaced by a 15-mm trocar for insertion of a double-channel endoscope (GIF 2T200; Olympus Optical Co., Tokyo, Japan) ([Fig. 1]). In addition, another 3-mm trocar was inserted in the left hypochondrium, to be used for retracting the gallbladder fundus. This port was also used to insufflate carbon dioxide and to monitor the pneumoperitoneum.

The main working instrument was, however, the double-channel endoscope. Through the left working channel, a rat-toothed biopsy forceps was introduced to grasp the infundibulum. A hot-biopsy forceps was inserted through the right instrumentation channel to divide the peritoneum overlying Calot’s triangle ([Fig. 2]). We commenced the dissection close to the gallbladder with the diathermic endocut mode (ERBE ICC 350; Electromedizin, Tübingen, Germany). Endoclips (Resolution; Boston Scientific, Natick, Massachusetts, USA) were next used to secure the cystic artery in three patients, while in one the thin pedicle was divided with electrocautery ([Fig. 3]), and in the remaining six patients endoclips were used. The cystic duct was skeletonized and endoclips were placed, so that it could be divided ([Fig. 4]). An endosnare was applied to the cut end of the infundibulum to aid in manipulation and traction during dissection of the gallbladder bed ([Fig. 5] [6]). Dissection at this stage had to be extremely careful so as not to puncture the gallbladder and cause bile leak. If this happens, it cannot be sucked clean as suction probes for endoscopic use are currently not available. Excess smoke from diathermic cautery was evacuated out through the 3-mm trocar in the left hypochondrium. The specimen was finally retrieved through the umbilical access ([Fig. 7]). The umbilical wound was closed after thorough cleaning with an antiseptic solution.

For these procedures, a dedicated endoscope was used which was disinfected after each use; manual cleaning and rinsing of all exposed internal and external surfaces with a low-foaming enzymatic detergent was followed by high-level disinfection with Cidex OPA solution for 12 minutes at 200 °C. The decontamination was concluded with further rinsing with sterile water, followed by drying and storing of the endoscope.

Results

Of the 10 patients recruited, 4 were men. The mean age was 29.5 years (range 25 - 34 years) and mean body mass index 23.95 (range 20.2 - 27.7) The procedure was successfully completed as intended in 6 of the 10 patients, with conversion to laparoscopic cholecystectomy in the remaining 4. In the first 2 patients, the endoscopic procedure could not be completed due to uncontrollable hemorrhage from the cystic artery. Among the next 8 patients, in patient 3 dissection of Calot’s triangle dissection was cumbersome, making the cystic duct and artery difficult to identify. In patient 5, the clip on the cystic duct did not hold well, resulting in a bile leak. For these reasons, the procedures in these 2 patients were converted as well. The mean operating time was 148 minutes (range 134 - 162 minutes). The length of hospital stay was 1 day in 7 cases and 2 days in 3 cases.

Of the six patients who successfully underwent transumbilical endoscopic cholecystectomy, hemorrhage from the cystic artery was seen in one and was controlled endoscopically by means of endoclips. Abdominal ultrasonography was performed on the 1st postoperative day in all six patients and revealed no intra-abdominal fluid collection. One patient was readmitted 4 days later with mild jaundice and fever. Ultrasound revealed a bilioma of about 90 ml, which was percutaneously aspirated under guidance. The cause of the leak was assumed to be a cystic duct leak due to clip slippage. Endoscopic retrograde cholangiopancreatography (ERCP) with bile duct stenting was performed and successfully relieved the bile leak. The stent was removed after 6 weeks and the patient recovered uneventfully thereafter.

There were no port-site hernias or infection. Three patients have completed follow-up at 3 months and the other 3 cases at 6 months. They did not report on any abdominal problems and 5 out of 6 patients were completely satisfied; the patient who underwent postoperative ERCP due to bile leakage was not satisfied.

Discussion

NOTES is based on the concept of performing surgery that leaves no scars by accessing the abdominal cavity through a natural orifice under endoscopic visualization. The basic concept of NOTES was first described in 1994 by Wilk [11], but did not become popular until the middle of this decade. A variety of intra-abdominal procedures such as diagnostic laparoscopy (including liver biopsy), cholecystectomy, splenectomy, tubal ligation, and others have been reported in animal experiments [12]. The pure concept of NOTES has been based on transluminal access and the use of flexible endoscopes. In patients, however, the first published applications have used a hybrid technique with one additional percutaneous trocar (e. g., through the umbilicus), and have revitalized the transvaginal access [12] using rigid laparoscopic instruments [5] [6] [7] [8] [9]. This transvaginal access seems to be safe and feasible in clinical application, but it is naturally limited to female patients. In our center we followed a different approach by using the umbilicus as the main port to introduce a flexible double-channel endoscope; a small additional port was only used to support the action of the endoscope to apply traction to the gallbladder fundus. Such an extra port was used in all reported transvaginal cholecystectomies [5] [6] [7] [8] [9]. The accessories we used are well known from conventional endoscopic procedures, namely needle-knife, hot-biopsy forceps (for monopolar cautery), rat-toothed grasper, endosnare, and clips.

To the best of our knowledge, the only publication in the literature reporting the use of the transumbilical route for flexible endoscopic surgery is a case report by Zhu [10], who performed an endoscopic liver cyst fenestration with appendectomy. Even though this approach, which is also used by us, is not pure NOTES, we are convinced it can be considered as endoscopic cholecystectomy using a ”natural scar” (i. e., the umbilicus) for intraperitoneal access. Currently, the transgastric or transcolonic approaches are the most discussed technique for NOTES, but they have only been published in animal experiments. There is still cause for concern, though, as gastrostomy and colostomy closure techniques are not yet perfect and may be associated with a leakage risk of 1 - 2 % [13] [14]. Trials are underway to produce a fool-proof sealing system, and until such time as this is found, other viable alternatives have to be explored [15]. ”Natural scar“ surgery through the umbilicus avoids the problems of access, closure, and infection, while maintaining the benefits of scarless surgery. The scar of the 3-mm port is negligible and the larger scar lies invisible within the umbilicus. It was our subjective impression that postoperative pain was less than in patients who undergo laparoscopic cholecystectomy in our center, who usually require at least one dose of opioids; this, however, was not systematically studied and awaits further objective assessment.

Due to various factors we had a high conversion and complication rate in this initial series. As could be expected, the operating times were obviously longer than for the conventional laparoscopic procedures, although we saw some reduction of operating time in the later procedures. Orientation and triangulation are inherent problems of endoscopic surgery that can be minimized with experienced assistants to hold the scope leaving the surgeon free to operate. Improved endoscopes will be of further help to optimize the various steps in the procedure. Endoscopic accessories are still imperfect, as shown by the cystic duct leakage; the bile leak was perhaps also caused by some kind of misplacement of the endoclip, reflecting our learning curve. Intraoperative hemorrhage from the cystic artery or its smaller branches is a problem that is well known from conventional laparoscopic cholecystectomy, so, on the one hand, it should not be considered a major setback; on the other hand, at least presently, management of bleeding is much easier with laparoscopic instruments than with a flexible endoscope.

It may be too early to speculate who should be doing and be trained in this kind of procedure. In our center, all NOTES procedures are performed by surgeons, assisted by endoscopists and endoscopy-trained nurses. There have been recent developments regarding instrumentation and optics, where better ergonomics are offered by new-generation therapeutic endoscopes [16]. Adequate experience must be obtained in animal models before venturing into NOTES procedures. At present, there is no definitive number of procedures that need to be performed in order to claim that the learning curve has been conquered, and to attempt procedures on human subjects. This will depend not only on individual training in animal models, but also on experience in both laparoscopic and endoscopic interventions, and may be facilitated by further instrument development.

In conclusion, even though our success rate and early results may not be such as to make it entirely acceptable to continue along these lines, we strongly believe that we can achieve a better outcome over time, given the abovementioned improvements. The incorporation of NOTES into routine surgical practice appears to us inevitable in the near future. For the present time, hybrid procedures like transumbilical endoscopic cholecystectomy seem to be a feasible option, with some patient benefits to be expected, such as reduced postoperative pain and better cosmesis, which will be shown in appropriate trials. This study is only an initial attempt at hybrid NOTES, and is by no means standardized. It could pave the way for further evaluation from specialist centers and encourage surgeons to eventually develop various methods more or less associated with NOTES approaches.

Competing interests: None

References

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  CrossrefPubMedSearch in Google Scholar
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C. Palanivelu, MCh, FRCS

GEM Hospital and Postgraduate Institute

45-A Pankaja Mill Road

Coimbatore 641045

India

Fax: +91-422-2320879

Email: drcp@gemhospital.net

References

• 1 Pai R D, Fong D G, Bundga M E. et al . Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model.  Gastrointest Endosc. 2006;  64 428-434
  CrossrefPubMedSearch in Google Scholar
• 2 Meining A, Wilhelm D, Burian M. et al . Development, standardization, and evaluation of NOTES cholecystectomy using a transsigmoid approach in the porcine model: an acute feasibility study.  Endoscopy. 2007;  39 860-864
  Thieme ConnectPubMedSearch in Google Scholar
• 3 Park P O, Bergström M, Ikeda K. et al . Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecysto-gastric anastomosis (videos).  Gastrointest Endosc. 2005;  61 601-606
  CrossrefPubMedSearch in Google Scholar
• 4 Lima E, Rolanda C, Pêgo J M. et al . Transvesical endoscopic peritoneoscopy: a novel 5 mm port for intra-abdominal scarless surgery.  J Urol. 2006;  176 802-805
  CrossrefPubMedSearch in Google Scholar
• 5 Bessler M, Stevens P D, Milone L. et al . Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery.  Gastrointest Endosc. 2007;  66 1243-1245
  CrossrefPubMedSearch in Google Scholar
• 6 Zorron R, Maggioni L C, Pombo L. et al . NOTES transvaginal cholecystectomy: preliminary clinical application.  Surg Endosc. 2008;  22 542-547
  CrossrefPubMedSearch in Google Scholar
• 7 Branco Filho A J, Noda R W, Kondo W. et al . Initial experience with hybrid transvaginal cholecystectomy.  Gastrointest Endosc. 2007;  66 1245-1248
  CrossrefPubMedSearch in Google Scholar
• 8 Zornig C, Emmermann A, von Waldenfels H A, Mofid H. Laparoscopic cholecystectomy without visible scar: combined transvaginal and transumbilical approach.  Endoscopy. 2007;  39 913-915
  Thieme ConnectPubMedSearch in Google Scholar
• 9 Marescaux J, Dallemagne B, Perretta S. et al . Surgery without scars: report of transluminal cholecystectomy in a human being.  Arch Surg. 2007;  142 823-826
  CrossrefPubMedSearch in Google Scholar
• 10 Zhu J F. Scarless endoscopic surgery: NOTES or TUES.  Surg Endosc. 2007;  21 1898-1899
  CrossrefPubMedSearch in Google Scholar
• 11 Wilk P J. Method for use in intra-abdominal surgery. 1994 US Patent device 5,297,536
  Search in Google Scholar
• 12 Gordts S, Puttemans P, Gordts S. et al . Transvaginal laparoscopy.  Best Pract Res Clin Obstet Gynaecol. 2005;  19 757-767
  CrossrefPubMedSearch in Google Scholar
• 13 Sclabas G M, Swain P, Swanstrom L L. Endoluminal methods for gastrotomy closure in natural orifice transenteric surgery (NOTES).  Surg Innov. 2006;  13 23-30
  CrossrefPubMedSearch in Google Scholar
• 14 Magno P, Giday S A, Dray X. et al . A new stapler-based full-thickness transgastric access closure: results from an animal pilot trial.  Endoscopy. 2007;  39 876-880
  Thieme ConnectPubMedSearch in Google Scholar
• 15 Swain P. The ShapeLock system adapted to intragastric and transgastric surgery.  Endoscopy. 2007;  39 466-470
  Thieme ConnectPubMedSearch in Google Scholar
• 16 Pasricha P J, Kozarek R, Swain P. et al . A next generation therapeutic endoscope: development of a novel endoluminal surgery system with ”birds-eye” visualization and triangulating instruments.  Gastrointest Endosc. 2005;  61 AB106
  PubMedSearch in Google Scholar

C. Palanivelu, MCh, FRCS

GEM Hospital and Postgraduate Institute

45-A Pankaja Mill Road

Coimbatore 641045

India

Fax: +91-422-2320879

Email: drcp@gemhospital.net