Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

Tourniquet Clinical Trial

Official title:

Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277065
• Other study ID #: 1234
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2020
• Source: The Second Hospital of Anhui Medical University
• Contact: Liang He, Master
• Phone: 13655600231
• Email: heliang20062007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Liver Resection
• Tourniquet
• Vascular Occlusion

Intervention

Procedure:
• BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection
Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.
• cotton tourniquet
cotton tourniquet

Locations

Country	Name	City	State
China	The 2nd affiliated hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
hui hou

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Review. — View Citation

Dua MM, Worhunsky DJ, Hwa K, Poultsides GA, Norton JA, Visser BC. Extracorporeal Pringle for laparoscopic liver resection. Surg Endosc. 2015 Jun;29(6):1348-55. doi: 10.1007/s00464-014-3801-6. Epub 2014 Aug 27. — View 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 — View 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. — View 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. — View 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. Epub 2007 Sep 18. — View Citation

Rotellar F, Pardo F, Bueno A, Martí-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	the volume of blood loss	intraoperative
Secondary	Liver functional recovery	AST(glutamic oxalacetic transaminase, u/l)	up to 7 days after liver resection
Secondary	Postoperative complication(Rates in different grades)	According to The Clavien-Dindo Classification,https://www.assessurgery.com/clavien-dindo-classification/	up to 30 days after liver resection
Secondary	Mortality rates	the rate of postoperative death	up to 30 days after liver resection
Secondary	Hospital duration after operation (days)	the length of hospital stay	up to 30 days after liver resection
Secondary	Operation time(min)	the during of operation	intraoperative
Secondary	Blood transfusion (times and units)	intraoperative blood transfusion	intraoperative
Secondary	the clamping and declamping time(s)	the clamping and declamping time of using bulldog or cotton	intraoperative
Secondary	Duration of abdominal drain (days)	Duration of abdominal drain	up to 14 days after liver resection
Secondary	Duration to first flatus (days)	Duration to first flatus	up to 14 days after liver resection
Secondary	Comfort questionnaire measures (GCQ) measures by Kolcaba	GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html	up to 30 days after liver resection
Secondary	Intensive care unit stay(days)	Intensive care unit stay in days	up to 7 days after liver resection
Secondary	Liver functional recovery	ALT(glutamic-pyruvic transaminase enzyme,u/l)	up to 7 days after liver resection
Secondary	Liver functional recovery	TB(total bilirubin,µmol/L)	up to 7 days after liver resection
Secondary	Liver functional recovery	ALB(albumin,g/L)	up to 7 days after liver resection
Secondary	Liver functional recovery	TP(total protein,g/L)	up to 7 days after liver resection