Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy

NCT05490147 | Unknown DMC

• 1 other identifier: 2206-069-1332
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.

Conditions

Ventilator Lung; Liver Cirrhosis; Hepatocellular Carcinoma; Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  amount drained from peritoneal cavity - irrigation fluid

  during surgery

Secondary Outcomes (11)

• postoperative lung complications

  op end ~ postoperative 2 weeks

• transfusion amount

  op. end ~ postoperative day 3

• postoperative hemoglobin level

  op. end ~ postoperative day 3

• postoperative total bilirubin level

  op. end ~ postoperative day 3

• postoperative PT INR level

  op. end ~ postoperative day 3

Study Arms (2)

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

EXPERIMENTAL

In the conventional tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 10\~12 throughout the surgery.

Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

EXPERIMENTAL

In the low tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 6\~8 throughout the surgery.

Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

Interventions

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group PROCEDURE

In the conventional tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 10\~12.

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume PROCEDURE

In the low tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 6\~8.

low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments

You may not qualify if:

• ASA class \>4
• patients with chronic obstructive pulmonary disease
• patients with Child-Pugh score C
• patients with arrythmia

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (11)

• Hendi M, Lv J, Cai XJ. Current status of laparoscopic hepatectomy for the treatment of hepatocellular carcinoma: A systematic literature review. Medicine (Baltimore). 2021 Dec 17;100(50):e27826. doi: 10.1097/MD.0000000000027826.

  PMID: 34918631 BACKGROUND

• Nomi T, Fuks D, Govindasamy M, Mal F, Nakajima Y, Gayet B. Risk factors for complications after laparoscopic major hepatectomy. Br J Surg. 2015 Feb;102(3):254-60. doi: 10.1002/bjs.9726. Epub 2014 Dec 17.

  PMID: 25522176 BACKGROUND

• Jones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60. doi: 10.1046/j.1365-2168.1998.00795.x.

  PMID: 9717995 BACKGROUND

• Kobayashi S, Honda G, Kurata M, Tadano S, Sakamoto K, Okuda Y, Abe K. An Experimental Study on the Relationship Among Airway Pressure, Pneumoperitoneum Pressure, and Central Venous Pressure in Pure Laparoscopic Hepatectomy. Ann Surg. 2016 Jun;263(6):1159-63. doi: 10.1097/SLA.0000000000001482.

  PMID: 26595124 BACKGROUND

• Gao X, Xiong Y, Huang J, Zhang N, Li J, Zheng S, Lu K, Ma D, Yang B, Ning J. The Effect of Mechanical Ventilation With Low Tidal Volume on Blood Loss During Laparoscopic Liver Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1033-1041. doi: 10.1213/ANE.0000000000005242.

  PMID: 33060490 BACKGROUND

• Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f.

  PMID: 19300227 BACKGROUND

• Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2013 Oct 23.

  PMID: 24150192 BACKGROUND

• Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.

  PMID: 26206652 BACKGROUND

• Ratti F, Cipriani F, Reineke R, Catena M, Paganelli M, Comotti L, Beretta L, Aldrighetti L. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial. HPB (Oxford). 2016 Feb;18(2):136-144. doi: 10.1016/j.hpb.2015.09.005. Epub 2015 Nov 17.

  PMID: 26902132 BACKGROUND

• Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

  PMID: 23902482 BACKGROUND

• Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18.

  PMID: 26643098 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Blood Loss, Surgical

Interventions

Tidal Volume; Population Groups

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Hemorrhage; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Demography; Population Characteristics

Study Officials

• Seong Mi Yang

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Mi Yang

CONTACT

+82-10-7300-6282; seongmi.yang@gmail.com

Hye-Yeon Cho

CONTACT

bdbd7799@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a surgeon blinded randomized controlled study

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 5, 2022
• Study Start: August 8, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-07

Locations

KR (1)