Clinical trialPhase 3Unknown
Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy
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
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Unknown
- Study type
- Interventional
- Start
- August 2016
- Expected end
- February 2020
- Enrollment
- 304 participants
- Sites
- 1
- Primary outcomes
- the incidence of pancreatic fsitula grade B/C
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 August 2016
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Papers 2
- Registry-listed results paperSafety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A No… DOI 10.1001/jamasurg.2021.0108↗
- Builds on itSplenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenc… DOI 10.1186/s13063-018-2756-7↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.