Clinical trial NCT02871804: Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy
Official title: Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Neoplasms
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 304
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).

Detailed description: In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.

Eligibility criteria: Inclusion Criteria:

* Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
* ECOG Performance Status (PS) = 0-1
* Age ≥ 20 years old
* Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent

Exclusion Criteria:

* Splenic vein-preserving distal pancreatectomy
* Superior mesenteric vein or portal vein invasion
* Pancreatic trauma
* Preoperative inflammatory pancreatic disease (pancreatitis)
* Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
* Severe ischemic cardiovascular disease
* Liver cirrhosis or active hepatitis
* Need for oxygen due to interstitial pneumonia or lung fibrosis
* Dialysis due to chronic renal failure
* Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
* Active multiple cancer that is thought to influence the occurrence of adverse events
* Difficulty with study participation due to psychotic disease or symptoms
* Inappropriate use of the stapler
* Inappropriate for the study objectives

Primary outcomes:
measure: the incidence of pancreatic fsitula grade B/C
timeFrame: 6 months after operation
Secondary outcomes:
measure: the incidence of pancreatic fsitula of all grades
timeFrame: 6 months after operation
measure: the incidence of pancreatic fsitula grade C
timeFrame: 6 months after operation
measure: the incidenceof intra-abdominal haemorrhage
timeFrame: 6 months after operation
measure: the incidence of all complications
timeFrame: 6 months after operation
measure: comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C
timeFrame: 6 months after operation
measure: mortality
timeFrame: 6 months after operation
measure: the incidence of thrombosis of the splenic vein
timeFrame: 6 months after operation
measure: the operative time
timeFrame: during operation
measure: volume of blood loss
timeFrame: during operation
measure: thickness of the resected pancreatic parenchyma
timeFrame: during operation
measure: haemostasis of the staple line
timeFrame: during operation
measure: integrity of the staple line
timeFrame: during operation
measure: the incidence of pancreatic injury
timeFrame: during operation
measure: need for additional sutures to securely close the pancreatic stump
timeFrame: during operation
measure: time needed for pancreatic transection
timeFrame: during operation
measure: duration of drainage tube placement
timeFrame: 6 months after operation
measure: postoperative hospital stay duration
timeFrame: 6 months after operation
measure: the incidence of conversion from laparoscopic surgery to open surgery
timeFrame: during operation
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Hiroki Yamaue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamada S, Fujii T, Sonohara F, Kawai M, Shibuya K, Matsumoto I, Fukuzawa K, Baba H, Aoki T, Unno M, Satoi S, Kishi Y, Hatano E, Uemura K, Horiguchi A, Sho M, Takeda Y, Shimokawa T, Kodera Y, Yamaue H. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):418-428. doi: 10.1001/jamasurg.2021.0108.
citation: Yamada S, Fujii T, Kawai M, Shimokawa T, Nakamura M, Murakami Y, Satoi S, Eguchi H, Nagakawa Y, Kodera Y, Yamaue H. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):369. doi: 10.1186/s13063-018-2756-7.