Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University

About this trial

This study aims to compare the surgical outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique versus the Warshaw technique. The primary focus is on the rates of unplanned splenectomy, occurrence of severe complications, as well as intraoperative and perioperative outcomes of both techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 70 years, regardless of gender.

Preoperative clinical diagnosis of benign or low-grade malignant pancreatic tumors.

Meeting the recommended surgical indications as per guidelines.

Feasibility of imaging assessment for either Kimura or Warshaw technique laparoscopic spleen-preserving distal pancreatectomy.

Disqualifiers

Body Mass Index (BMI) > 28 kg/m2 (Chinese obesity standard).

History of blood disorders, acute or chronic pancreatitis, gastrointestinal bleeding, splenic rupture, or gastric varices (preoperative CT indicating curved vessel structures along the gastric wall with a diameter > 5mm).

History of abdominal surgery.

Concomitant primary malignant tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique

    Procedure/Surgery

    The laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique is defined as a surgical procedure that aims to remove the distal part of the pancreas while preserving the spleen by maintaining the splenic artery and vein (Hepatogastroenterology. 2003;50:2242).

  • Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique

    Procedure/Surgery

    Warshaw technique laparoscopic spleen-preserving distal pancreatectomy is defined as a surgical procedure that aims to preserve the spleen while removing the distal part of the pancreas. It involves ligating the splenic artery and vein, while preserving the left gastroepiploic artery and short gastric vessels (Arch Surg. 1988;123:550).

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Kimura groupExperimental treatment 1 intervention
Group B: Warshaw groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Unplanned splenectomy rate

The unplanned splenectomy rate in both groups will be calculated, and detailed records of the specific reasons will be documented, such as adhesions, bleeding, intraoperative splenic infarction.

Time frame
Immediately after the surgery.
2

Severe complication rate

The rate of severe complications will be assessed by evaluating the severity of postoperative complications using the Clavien-Dindo classification system. In this classification system, complications graded as III and above are considered severe complications.

Time frame
Within 90 days after surgery.

Secondary outcomes

1

Spleen vessel preservation rate

The spleen vessel preservation rate refers to the rate at which the spleen vessels are successfully preserved during surgery. In cases where the Kimura technique is unable to preserve the spleen vessels, salvage Warshaw procedure or splenectomy may be performed. This can include modified Warshaw procedures that involve the simple removal of the splenic artery or splenic vein.

Time frame
Immediately after the surgery.
2

Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate

CRSI is defined as the occurrence of spleen ischemia requiring splenectomy during either the initial hospitalization or subsequent readmissions. The reasons for the second splenectomy will be recorded.

Time frame
Through study completion, an average of 3 year.
3

Postoperative quality of life assessment

The evaluation will be conducted using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used questionnaire to assess the quality of life. It consists of multiple scales and items that cover various aspects of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, global health status, and symptom scales. Each item in the questionnaire is rated on a four-point Likert scale, ranging from 1 (not at all) to 4 (very much). Some items are reverse-scored, meaning that a higher score indicates a worse outcome. The scores for each scale are then transformed to a 0-100 scale, where a higher score represents a better outcome for functioning scales and a worse outcome for symptom scales.

Time frame
Through study completion, an average of 3 year.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

The Third Affiliated Hospital of Soochow University

Collaborator

Tongji Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: