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

NCT06167421 | Not Yet Recruiting DMC

• 1 other identifier: CSPAC-7
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Tumor, Benign; Pancreatic Neuroendocrine Tumor; Solid Pseudopapillary Tumor of the Pancreas

Keywords

Pancreatic benign or low-grade malignant tumors; Minimally invasive spleen-preserving distal pancreatectomy; Kimura technique; Warshaw technique; Prognosis

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately after the surgery.

• 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.

  Within 90 days after surgery.

Secondary Outcomes (3)

• Spleen vessel preservation rate

  Immediately after the surgery.

• Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate

  Through study completion, an average of 3 year.

• Postoperative quality of life assessment

  Through study completion, an average of 3 year.

Study Arms (2)

Kimura group

EXPERIMENTAL

Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique.

Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique

Warshaw group

ACTIVE COMPARATOR

Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique.

Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique

Interventions

Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique PROCEDURE

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).

Kimura group

Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique PROCEDURE

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).

Warshaw group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) score.
• Willingness to comply with the study treatment plan, follow-up schedule, and other protocol requirements.
• Voluntarily participating in the study and signing an informed consent form.

You may not qualify if:

• 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.
• Suspicion of malignancy based on PET-CT or other imaging examinations.
• Severe impairment of cardiac, liver, or kidney function (NYHA class 3-4, ALT and/or AST exceeding three times the upper limit of normal, Creatinine exceeding the upper limit of normal).
• Planned pregnancy or pregnancy and lactating women.
• Participants currently involved in other clinical trials.

Sponsors & Collaborators

• Fudan University: lead
• 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

Related Publications (9)

• de Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams F, van Dam R, Dejong C, van Duyn E, Dijkgraaf M, van Eijck C, Festen S, Gerhards M, Groot Koerkamp B, de Hingh I, Kazemier G, Klaase J, de Kleine R, van Laarhoven C, Luyer M, Patijn G, Steenvoorde P, Suker M, Abu Hilal M, Busch O, Besselink M; Dutch Pancreatic Cancer Group. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial. Ann Surg. 2019 Jan;269(1):2-9. doi: 10.1097/SLA.0000000000002979.

  PMID: 30080726 BACKGROUND

• Asbun HJ, Moekotte AL, Vissers FL, Kunzler F, Cipriani F, Alseidi A, D'Angelica MI, Balduzzi A, Bassi C, Bjornsson B, Boggi U, Callery MP, Del Chiaro M, Coimbra FJ, Conrad C, Cook A, Coppola A, Dervenis C, Dokmak S, Edil BH, Edwin B, Giulianotti PC, Han HS, Hansen PD, van der Heijde N, van Hilst J, Hester CA, Hogg ME, Jarufe N, Jeyarajah DR, Keck T, Kim SC, Khatkov IE, Kokudo N, Kooby DA, Korrel M, de Leon FJ, Lluis N, Lof S, Machado MA, Demartines N, Martinie JB, Merchant NB, Molenaar IQ, Moravek C, Mou YP, Nakamura M, Nealon WH, Palanivelu C, Pessaux P, Pitt HA, Polanco PM, Primrose JN, Rawashdeh A, Sanford DE, Senthilnathan P, Shrikhande SV, Stauffer JA, Takaori K, Talamonti MS, Tang CN, Vollmer CM, Wakabayashi G, Walsh RM, Wang SE, Zinner MJ, Wolfgang CL, Zureikat AH, Zwart MJ, Conlon KC, Kendrick ML, Zeh HJ, Hilal MA, Besselink MG; International Study Group on Minimally Invasive Pancreas Surgery (I-MIPS). The Miami International Evidence-based Guidelines on Minimally Invasive Pancreas Resection. Ann Surg. 2020 Jan;271(1):1-14. doi: 10.1097/SLA.0000000000003590.

  PMID: 31567509 BACKGROUND

• Korrel M, Jones LR, van Hilst J, Balzano G, Bjornsson B, Boggi U, Bratlie SO, Busch OR, Butturini G, Capretti G, Casadei R, Edwin B, Emmen AMLH, Esposito A, Falconi M, Groot Koerkamp B, Keck T, de Kleine RHJ, Kleive DB, Kokkola A, Lips DJ, Lof S, Luyer MDP, Manzoni A, Marudanayagam R, de Pastena M, Pecorelli N, Primrose JN, Ricci C, Salvia R, Sandstrom P, Vissers FLIM, Wellner UF, Zerbi A, Dijkgraaf MGW, Besselink MG, Abu Hilal M; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial. Lancet Reg Health Eur. 2023 Jul 6;31:100673. doi: 10.1016/j.lanepe.2023.100673. eCollection 2023 Aug.

  PMID: 37457332 BACKGROUND

• Casciani F, Trudeau MT, Vollmer CM Jr. Perioperative Immunization for Splenectomy and the Surgeon's Responsibility: A Review. JAMA Surg. 2020 Nov 1;155(11):1068-1077. doi: 10.1001/jamasurg.2020.1463.

  PMID: 32936229 BACKGROUND

• Korrel M, Lof S, Al Sarireh B, Bjornsson B, Boggi U, Butturini G, Casadei R, De Pastena M, Esposito A, Fabre JM, Ferrari G, Fteriche FS, Fusai G, Koerkamp BG, Hackert T, D'Hondt M, Jah A, Keck T, Marino MV, Molenaar IQ, Pessaux P, Pietrabissa A, Rosso E, Sahakyan M, Soonawalla Z, Souche FR, White S, Zerbi A, Dokmak S, Edwin B, Hilal MA, Besselink M; European consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Short-term Outcomes After Spleen-preserving Minimally Invasive Distal Pancreatectomy With or Without Preservation of Splenic Vessels: A Pan-European Retrospective Study in High-volume Centers. Ann Surg. 2023 Jan 1;277(1):e119-e125. doi: 10.1097/SLA.0000000000004963. Epub 2021 Jun 2.

  PMID: 34091515 BACKGROUND

• Yongfei H, Javed AA, Burkhart R, Peters NA, Hasanain A, Weiss MJ, Wolfgang CL, He J. Geographical variation and trends in outcomes of laparoscopic spleen-preserving distal pancreatectomy with or without splenic vessel preservation: A meta-analysis. Int J Surg. 2017 Sep;45:47-55. doi: 10.1016/j.ijsu.2017.07.078. Epub 2017 Jul 21.

  PMID: 28735894 BACKGROUND

• Warshaw AL. Conservation of the spleen with distal pancreatectomy. Arch Surg. 1988 May;123(5):550-3. doi: 10.1001/archsurg.1988.01400290032004.

  PMID: 3358679 BACKGROUND

• Ferrone CR, Konstantinidis IT, Sahani DV, Wargo JA, Fernandez-del Castillo C, Warshaw AL. Twenty-three years of the Warshaw operation for distal pancreatectomy with preservation of the spleen. Ann Surg. 2011 Jun;253(6):1136-9. doi: 10.1097/SLA.0b013e318212c1e2.

  PMID: 21394008 BACKGROUND

• Granieri S, Bonomi A, Frassini S, Gjoni E, Germini A, Kersik A, Bracchetti G, Bruno F, Paleino S, Lomaglio L, Frontali A, Cotsoglou C. Kimura's vs Warshaw's technique for spleen preserving distal pancreatectomy: a systematic review and meta-analysis of high-quality studies. HPB (Oxford). 2023 Jun;25(6):614-624. doi: 10.1016/j.hpb.2023.02.009. Epub 2023 Mar 1.

  PMID: 36941150 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianjun Yu, MD, PhD

CONTACT

+86-13801669875; yuxianjun@fudanpci.org

Zheng Li, MD

CONTACT

+86-18521097686; lizheng@fudanpci.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 12, 2023

Record last verified: 2023-12