Pancreatic Tumor, BenignNCT06167421
Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy
A study testing Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique and Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique in people with Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- What is being tested?
- Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique and Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy: A Multicenter Randomized Controlled Clinical 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.
Read the detailed description
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.
- Conditions
- Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the Pancreas
- Being tested
- Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique, Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
- Keywords
- Pancreatic benign or low-grade malignant tumors, Minimally invasive spleen-preserving distal pancreatectomy, Kimura technique, Warshaw technique, Prognosis
- Medical subject headings
- Pancreatic Neoplasms, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic spleen-preserving distal pancreatectomy using the Kimura techniqueProcedure or 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 techniqueProcedure or 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).
| Study group | Role | What they receive |
|---|---|---|
| Kimura group | Experimental | Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique. Receives: Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique |
| Warshaw group | Active comparator | Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique. Receives: Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 90 days after surgery.
Secondary outcomes (3)
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.
Measured: Immediately after the surgery.
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.
Measured: Through study completion, an average of 3 year.
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.
Measured: Through study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Tumor, BenignStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Qilu Hospital of Shandong University, The Third Affiliated Hospital of Soochow University, Tongji Hospital
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167421
- Sponsor's protocol ID
- CSPAC-7
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30080726Asbun 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.
PubMed 31567509Korrel 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.
PubMed 37457332Casciani 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.
PubMed 32936229Korrel 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.
PubMed 34091515Yongfei 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.
PubMed 28735894Warshaw AL. Conservation of the spleen with distal pancreatectomy. Arch Surg. 1988 May;123(5):550-3. doi: 10.1001/archsurg.1988.01400290032004.
PubMed 3358679Ferrone 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.
PubMed 21394008Granieri 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.
PubMed 36941150
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy: A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06167421
- Acronym / sponsor ID
- CSPAC-7
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Qilu Hospital of Shandong University, The Third Affiliated Hospital of Soochow University, Tongji Hospital
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kimura group | Experimental | Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Kimura techniqueLaparoscopic spleen-preserving distal pancreatectomy using the Kimura technique. |
| Warshaw group | Active comparator | Procedure: Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw techniqueLaparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic spleen-preserving distal pancreatectomy using the Kimura techniqueThe 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). | Procedure or surgery | Kimura group |
| Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw techniqueWarshaw 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). | Procedure or surgery | Warshaw group |
Primary outcome
Unplanned splenectomy rate
Time frame: Immediately after the surgery.
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.
Severe complication rate
Time frame: Within 90 days after surgery.
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.
3 secondary outcomes
Spleen vessel preservation rate
Time frame: Immediately after the surgery.
Postoperative Clinically Relevant Spleen Ischemia (CRSI) rate
Time frame: Through study completion, an average of 3 year.
Postoperative quality of life assessment
Time frame: Through study completion, an average of 3 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 30080726de 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.
- Background: PubMed 31567509Asbun 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.
- Background: PubMed 37457332Korrel 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.
- Background: PubMed 32936229Casciani 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.
- Background: PubMed 34091515Korrel 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.
- Background: PubMed 28735894Yongfei 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.
- Background: PubMed 3358679Warshaw AL. Conservation of the spleen with distal pancreatectomy. Arch Surg. 1988 May;123(5):550-3. doi: 10.1001/archsurg.1988.01400290032004.
- Background: PubMed 21394008Ferrone 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.
- Background: PubMed 36941150Granieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianjun Yu, MD, PhD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic spleen-preserving distal pancreatectomy using the Kimura technique and Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique in people with Pancreatic Tumor, Benign and Pancreatic Neuroendocrine Tumor, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, MD, PhD (+86-13801669875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned splenectomy rate (time frame: Immediately after the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06167421, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.