To Evaluate If Preoperative 7 Days Low Calorie Diet Reduces Postoperative Morbidity in Liver Surgery (LowCaLi)

August 31, 2026 updated by: Region Skane

Low Calorie Diet Before Liver Surgery - A Nordic Multicentre Randomized Controlled Trial

The rationale for this study is to evaluate whether a standardized, preoperative, short-term Low Calorie Diet (LCD) reduces intraoperative bleeding and postoperative morbidity in liver surgery.

Participants with a BMI of 30 or higher, scheduled for liver surgery, if accepting participation, will be randomized to a 7 day LCD or no intervention.

A previous small single center RCT have shown significantly reduced intraoperative blood loss and a tendency towards less postoperative complications. This multi-centre study aims to include enough patients with power to analyze also postoperative complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The LowCaLi study is a multicentre, open-label, randomized controlled trial.

Hypothesis

  • A 7-day preoperative LCD reduces postoperative complications.
  • LCD reduces intraoperative bleeding and postoperative complication rate.
  • LCD reduces liver volume, facilitates access, and shortens operating time.
  • LCD decreases hepatic glycogen and steatosis.
  • LCD improves coagulation.
  • LCD modifies plasma lipid and fatty acid composition.

Primary Objective To investigate whether a 7-day preoperative LCD reduces postoperative complications as measured by the Comprehensive Complication Index (CCI).

Secondary Objectives

  • To assess the effect of LCD on intraoperative blood loss and transfusion requirements.
  • To evaluate parenchymal dissection time and total surgical duration.
  • To measure hospital length of stay.
  • To determine R0 resection rate (tumour-free margins).
  • To analyse systemic inflammatory response.
  • To evaluate compliance with the intervention.
  • To assess health-related quality of life (QLQ-C30).

Sample Size Calculation Barth et al. (2019) demonstrated a reduction in bleeding from 300 ml to 200 ml with LCD, requiring 32 patients for 80% power at α=0.05. For CCI reduction (21→13, SD=20), 98 patients per arm are required. To account for attrition, 200 patients (100 per group) will be recruited.

Study Procedures

  • Screening and randomization at preoperative visit
  • LCD intervention: 7 days prior to surgery
  • Follow-up phone calls during the intervention period
  • Structured intraoperative assessment by surgeon
  • Postoperative follow-up including complications, pathology, and length of stay
  • Patient-reported outcomes collected preoperatively and at 30 days postoperatively

Workflow Eligible patients will be identified during the mandatory pre-surgery outpatient visit. Written and oral study information will be provided, and informed consent obtained. Patients will then be randomized (1:1) using a web-based module in the eCRF (RedCap).

Randomization will be stratified by surgical approach (open vs. minimally invasive). The intervention group will follow a 7-day LCD (1000 kcal/day), using a standardized commercial product such as for example Modifast). The control group will receive standard preoperative care, including carbohydrate preloading, without diet restriction.

Study nurses will provide dietary instructions and monitor compliance through scheduled phone calls. Following surgery, the operating surgeon will complete a structured form documenting liver mobility, parenchymal texture, and intraoperative blood loss. Patient-reported quality of life will be assessed preoperatively and 30 days postoperatively.

Withdrawal of Individual Subjects Participation is voluntary. Patients may withdraw at any time without consequences for clinical care.

Follow-up of Subjects Withdrawn from Treatment Data collected up to the time of withdrawal will be included if the patient consents.

Statistical Analysis Primary analysis: comparison of CCI between groups using t-test or Mann-Whitney U test. Secondary analyses: regression models for continuous outcomes, chi-square/Fisher's exact tests for categorical data, and Kaplan-Meier analysis for time-to-event outcomes. Both intention-to-treat and per-protocol analyses will be performed.

ETHICAL CONSIDERATIONS Regulation Statement: The study will be conducted in accordance with the Declaration of Helsinki, ICH-GCP, and national legislation. Recruitment and Consent: To avoid bias, brief study information will be given to all eligible patients before randomization. Full dietary details will only be disclosed to participants allocated to the intervention group. Written informed consent is required prior to enrolment. The intervention group will be recieve LCD för 7 days or be compensated for the extra cost due to LCD diet, in arrears.

Compensation for Injury Patients are covered by national patient insurance schemes. No monetary compensation will be provided to participants.

ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION Handling and storage of data and documents The sponsor and the trial management team will oversee the conduct of the trial according to Good Clinical Practice (GCP). The local investigators will be responsible for conduct at their respective sites.

Data will be handled confidentially. Each patient will receive an anonymous identification code. To trace data, a subject identification code list will be used. Each participating site will keep the key to this code secure. The handling of data will comply with the EU General Data Protection Regulation (GDPR).

Data will be kept for a minimum of ten years according to current regulations. Data will be entered into the eCRF using the electronic online database RedCap. Data to be collected are derived from the protocol.

The CRF and instructions for completing it will be provided by the Clinical Trial Centre/Västra Götaland, Sweden.

Handling and Storage of Data and Documents

  • Data will be recorded in the eCRF (RedCap).
  • Source data will be extracted from medical records.
  • Records will be retained for at least 10 years after study completion.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Recruiting
        • Department och Surgery, Skane University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny Lundmark Rystedt, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled for open or minimally invasive liver resection
  • BMI ≥30

Exclusion Criteria:

  • Diagnosed liver cirrhosis
  • Perihilar tumours
  • Inability to understand written information in Swedish, Norwegian, Danish, or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard
Liver surgery standard of care
Experimental: Intervention
LCD
Dietary supplement: Low calorie meal replacement plan
Short-term LCD one week prio to liver surgery for patients with a BMI 30 or higher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: From 1 week before to 30 days after liver surgery
To investigate whether a 7-day preoperative LCD reduces postoperative complications as measured by the Comprehensive Complication Index (CCI). CCI=0 means no complications and CCI=100 means death.
From 1 week before to 30 days after liver surgery
Bleeding
Time Frame: During liver surgery
Total intraoperative bleeding measured in millilitres
During liver surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: During liver surgery
To investigate whether there is a difference in in total operating time measured in minutes including liver mobilisation and parenchymal dissection time specified.
During liver surgery
Length of hospital stay (LOS - from the day of surgery until discharge from the hospital)
Time Frame: From the day before surgery until 90 days postoperatively
To compare LOS measured in days between the groups
From the day before surgery until 90 days postoperatively
Radical resection (R0)
Time Frame: From surgery until definitive pathological report is documented in the medical records, ie an average of 3-12 weeks
Investigate if there is a difference in R0 between the intervention and control group. R0 defined as >1 mm tumor free margins.
From surgery until definitive pathological report is documented in the medical records, ie an average of 3-12 weeks
Health-related quality of life (QoL)
Time Frame: Preoperatively and 30 days postoperatively
Health-related QoL measured by QLQ-C30
Preoperatively and 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ethix dnr 2025-02719-01
  • SLS-1023200 (Other Grant/Funding Number: Swedish Society of Medicine)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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