Clinical trial NCT04277065: Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients
Official title: Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Liver Resection
Vascular Occlusion
Tourniquet
Keywords: Laproscopic hepatectomy
Bulldog
Vascular occlusion
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, postoperative mortality, mobility and recovery of liver function are associated with major blood loss which is always the main cause of conversion to laparotomy and remains a challenge for surgeons. Pringle first described the method to arrest the hepatic hemorrhage by compression of the porta hepatis and this procedure was widely spread as well as in laparoscopic feild currently. Here, we described a new modified of Pringle maneuver using Bulldog to block vascular during LLR, and compared its effects with traditional pringle maneuver.

Detailed description: With the innovations of laparoscopic technique and specialized equipment , laparoscopic liver resection became the dominating resection surgery approach. December of 2014, laparoscopic hepatectomy was carried out in our department, extracorporeal Pringle maneuver has been applied in most laparoscopic liver resections which need to block the hepatic inflow, cotton tape was the frequently used tourniquet. We used to blocked the hepatic inflow by extracorporeal Pringle maneuver method with cotton tape for its validity , softness and no visible damages for vessel, but it was always difficult for clamping in a two-dimensional view to encircle the hepatoduodenal ligament , and it delayed operation time for freshmen. Bulldog has been widely used in urinary surgery for vascular occlusion, but bulldog in hepatic surgery has rarely been mentioned, this is the first report to formally demonstrate the clinical application in hepatic surgery. However, it is not clear that whether the bulldog for vascular occlusion is useful and easy to implement in laparoscopic hepatectomy. In this study, we will compare the cotton and the bulldog for vascular occlusion during laparoscopic hepatectomy

Eligibility criteria: Inclusion Criteria:

* Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for laparoscopic liver resection
* Child-Pugh A without portal hypertension
* No portosystemic shunt
* No previous abdominal operation history
* American society of anesthesiology class(ASA): I or II
* Age 18 to 80

Exclusion Criteria:

* Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
* Emergence hepatectomy
* Previous hepatectomy
* Combined operation for extrahepatic disease
* Vulnerable population (mental retardation, pregnancy)

Primary outcomes:
measure: Blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: Liver functional recovery
timeFrame: up to 7 days after liver resection
measure: Postoperative complication(Rates in different grades)
timeFrame: up to 30 days after liver resection
measure: Mortality rates
timeFrame: up to 30 days after liver resection
measure: Hospital duration after operation (days)
timeFrame: up to 30 days after liver resection
measure: Operation time(min)
timeFrame: intraoperative
measure: Blood transfusion (times and units)
timeFrame: intraoperative
measure: the clamping and declamping time(s)
timeFrame: intraoperative
measure: Duration of abdominal drain (days)
timeFrame: up to 14 days after liver resection
measure: Duration to first flatus (days)
timeFrame: up to 14 days after liver resection
measure: Comfort questionnaire measures (GCQ) measures by Kolcaba
timeFrame: up to 30 days after liver resection
measure: Intensive care unit stay(days)
timeFrame: up to 7 days after liver resection
measure: Liver functional recovery
timeFrame: up to 7 days after liver resection
measure: Liver functional recovery
timeFrame: up to 7 days after liver resection
measure: Liver functional recovery
timeFrame: up to 7 days after liver resection
measure: Liver functional recovery
timeFrame: up to 7 days after liver resection
Other outcomes:
Locations:
city: Hefei
country: China
facility: The 2nd affiliated hospital of Anhui Medical University
state: Anhui
Study officials:
References:
citation: Maehara S, Adachi E, Shimada M, Taketomi A, Shirabe K, Tanaka S, Maeda T, Ikeda K, Higashi H, Maehara Y. Clinical usefulness of biliary scope for Pringle's maneuver in laparoscopic hepatectomy. J Am Coll Surg. 2007 Dec;205(6):816-8. doi: 10.1016/j.jamcollsurg.2007.06.297. Epub 2007 Sep 18. No abstract available.
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citation: Ciria R, Cherqui D, Geller DA, Briceno J, Wakabayashi G. Comparative Short-term Benefits of Laparoscopic Liver Resection: 9000 Cases and Climbing. Ann Surg. 2016 Apr;263(4):761-77. doi: 10.1097/SLA.0000000000001413.
citation: Rotellar F, Pardo F, Bueno A, Marti-Cruchaga P, Zozaya G. Extracorporeal tourniquet method for intermittent hepatic pedicle clamping during laparoscopic liver surgery: an easy, cheap, and effective technique. Langenbecks Arch Surg. 2012 Mar;397(3):481-5. doi: 10.1007/s00423-011-0887-3. Epub 2011 Dec 20.
citation: Le B, Matulewicz RS, Eaton S, Perry K, Nadler RB. Comparative analysis of vascular bulldog clamps used in robot-assisted partial nephrectomy. J Endourol. 2013 Nov;27(11):1349-53. doi: 10.1089/end.2013.0367. Epub 2013 Oct 18.
citation: Kim WJ, Kim KH, Shin MH, Yoon YI, Lee SG. Totally laparoscopic anatomical liver resection for centrally located tumors: A single center experience. Medicine (Baltimore). 2017 Jan;96(4):e5560. doi: 10.1097/MD.0000000000005560.
citation: Ikeda T, Toshima T, Harimoto N, Yamashita Y, Ikegami T, Yoshizumi T, Soejima Y, Shirabe K, Maehara Y. Laparoscopic liver resection in the semiprone position for tumors in the anterosuperior and posterior segments, using a novel dual-handling technique and bipolar irrigation system. Surg Endosc. 2014 Aug;28(8):2484-92. doi: 10.1007/s00464-014-3469-y. Epub 2014 Mar 13.