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

Официальное название

Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy: A Multicenter Randomized Controlled Clinical Trial

Обзор

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.

Подробное описание

For benign and low-grade malignant tumors of the pancreatic body and tail, laparoscopic distal pancreatosplenectomy (LDP) is commonly recommended due to its shorter hospital stay, lower intraoperative blood loss, and comparable complication rates. The DIPLOMA international multicenter clinical trial further established the non-inferiority of minimally invasive techniques in terms of curative resection for resectable pancreatic body and tail cancers.

As the spleen plays a crucial role in immune defense, splenectomy is associated with increased postoperative infection risk, significant increase in platelet count, and thrombosis. Therefore, for benign and low-grade malignant tumors of the pancreatic body and tail, minimally invasive spleen-preserving distal pancreatectomy should be the preferred approach.

The Kimura technique is the most commonly used and favored spleen-preserving distal pancreatectomy technique. It involves the complete preservation of splenic vessels, resulting in fewer postoperative complications. However, it is time-consuming and challenging due to the identification and ligation of numerous small and short vessels entering the pancreatic body and tail to preserve the fragile splenic artery and vein. On the other hand, the Warshaw technique involves segmental resection of splenic vessels and relies on the left gastroepiploic artery and short gastric vessels for splenic perfusion. It is a simpler procedure with less intraoperative blood loss and shorter operative time. However, it carries an increased risk of postoperative splenic infarction, gastric varices, and secondary bleeding.

Although a higher incidence of splenic infarction has been observed with the Warshaw technique, its clinical relevance remains controversial. Reports indicate that approximately 25% of patients undergoing Warshaw procedure show radiological evidence of asymptomatic gastric varices, but during a follow-up period of up to 21 years, no clinically relevant consequences of gastric varices were observed. Most cases of postoperative splenic infarction are transient and do not require specific treatment. Data from a large pan-European retrospective study showed no significant differences in the clinical incidence of splenic infarction (0.6% vs. 1.6%, P = 0.127) and major complication rates (11.5% vs. 14.4%, P = 0.308) between minimally invasive Kimura and Warshaw techniques.

While Kimura and Warshaw techniques demonstrate comparability in most postoperative outcomes, the former appears to have an advantage in reducing the risk of splenic infarction and gastric varices. Some experts propose a "Kimura-first" strategy. However, there is currently no prospective study comparing these two techniques. Therefore, this study has designed a multicenter randomized controlled clinical trial, focusing on the rates of unplanned splenectomy, severe complication occurrence, and intraoperative and perioperative outcomes of laparoscopic spleen-preserving distal pancreatectomy using the Kimura versus the Warshaw technique. Long-term follow-up will assess clinically relevant outcomes such as splenic ischemia, splenic hyperfunction, gastric varices, and postoperative quality of life. This study aims to provide higher-level evidence in the selection of laparoscopic spleen-preserving distal pancreatectomy techniques.

Вмешательства

• Процедура Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique
  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).
• Процедура Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
  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).

Первичные конечные точки

• Unplanned splenectomy rate [Срок оценки: Immediately after the surgery.]
• Severe complication rate [Срок оценки: Within 90 days after surgery.]

Вторичные конечные точки (3)

• Spleen vessel preservation rate [Срок оценки: Immediately after the surgery.]
• Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate [Срок оценки: Through study completion, an average of 3 year.]
• Postoperative quality of life assessment [Срок оценки: Through study completion, an average of 3 year.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 Pancreatect PMID 30080726
• 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 PMID 31567509
• 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, Dijkgra PMID 37457332
• 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
• 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 Pancre PMID 34091515
• 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
• 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
• 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

Идентификаторы

NCT: NCT06167421 · CSPAC-7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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