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Study protocol
Efficacy of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for benign or low-grade malignant pancreatic tumors: study protocol for a randomized controlled trial
Jun-chao Guo
Peking Union Medical College Hospital
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Based on previous meta-analyses and comparative evidence, robotic approach might lead to a higher or at least similar spleen-preservation rates when comparing with laparoscopic approach in spleen preserving distal pancreatectomy (SPDP) for benign or low-grade malignant pancreatic tumors1–3. But high-quality evidence lacks and controversy exists. Therefore, we planned to initiate a prospective, patient-blinded, randomized, controlled trial (RCT) to compare robotic assisted spleen preserving distal pancreatectomy (RSPDP) with laparoscopic spleen preserving distal pancreatectomy (LSPDP), with special consideration to the success rate of splenic vessel-preserving (Kimura) approach, as well as perioperative variables, and cost analysis.
Methods
Patients with benign or low-grade malignant pancreatic tumors are potential candidates for this RCT. Enrolled participants are randomized into RSPDP (observational arm) or LSPDP (control arm) groups as a ratio of 1:1. The primary outcome is the success rate of splenic vessel-preserving (Kimura) approach. The secondary outcomes include total success rate of spleen preserving (Kimura and Warshaw approaches), intraoperative variables, time to functional recovery, postoperative complications, mortality, and cost/efficacy analysis.
Discussion
We plan to conduct a randomized controlled trial to detect the potential advantages of robotic approach in spleen vessels preservation compared with traditional laparoscopic approach. RSPDP may improve spleen vessels preservation rate in selected patients.
Trial registration
Chinese Clinical Trial Registry, No: ChiCTR2000029177. Registered on 18 January, 2020.
Keywords
Benign pancreatic tumor, Low grade malignant, Robotic distal pancreatectomy, Laparoscopic distal pancreatectomy, Spleen preservation
Figure 1
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CURRENT STATUS: Under Revision
Version 1
Posted 28 Sep, 2020
No community comments so far
Editorial decision: Major revision
On 05 Jan, 2021
Review #5 received
Received 18 Dec, 2020
Review #3 received
Received 12 Dec, 2020
Review #4 received
Received 12 Dec, 2020
Review #1 received
Received 11 Dec, 2020
Review #2 received
Received 09 Dec, 2020
Reviewer #5 agreed
On 01 Dec, 2020
Reviewer #4 agreed
On 30 Nov, 2020
Reviewer #2 agreed
On 28 Nov, 2020
Reviewer #3 agreed
On 28 Nov, 2020
Reviewer #1 agreed
On 28 Nov, 2020
Reviewers invited
Invitations sent on 07 Nov, 2020
Editor assigned
On 05 Nov, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 22 Jul, 2020
Metrics
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Subject Areas
Robotics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Efficacy of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for benign or low-grade malignant pancreatic tumors: study protocol for a randomized controlled trial
Jun-chao Guo
Peking Union Medical College Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Revision
Version 1
Posted 28 Sep, 2020
No community comments so far
Editorial decision: Major revision
On 05 Jan, 2021
Review #5 received
Received 18 Dec, 2020
Review #3 received
Received 12 Dec, 2020
Review #4 received
Received 12 Dec, 2020
Review #1 received
Received 11 Dec, 2020
Review #2 received
Received 09 Dec, 2020
Reviewer #5 agreed
On 01 Dec, 2020
Reviewer #4 agreed
On 30 Nov, 2020
Reviewer #2 agreed
On 28 Nov, 2020
Reviewer #3 agreed
On 28 Nov, 2020
Reviewer #1 agreed
On 28 Nov, 2020
Reviewers invited
Invitations sent on 07 Nov, 2020
Editor assigned
On 05 Nov, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 22 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Robotics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Based on previous meta-analyses and comparative evidence, robotic approach might lead to a higher or at least similar spleen-preservation rates when comparing with laparoscopic approach in spleen preserving distal pancreatectomy (SPDP) for benign or low-grade malignant pancreatic tumors1–3. But high-quality evidence lacks and controversy exists. Therefore, we planned to initiate a prospective, patient-blinded, randomized, controlled trial (RCT) to compare robotic assisted spleen preserving distal pancreatectomy (RSPDP) with laparoscopic spleen preserving distal pancreatectomy (LSPDP), with special consideration to the success rate of splenic vessel-preserving (Kimura) approach, as well as perioperative variables, and cost analysis.
Methods
Patients with benign or low-grade malignant pancreatic tumors are potential candidates for this RCT. Enrolled participants are randomized into RSPDP (observational arm) or LSPDP (control arm) groups as a ratio of 1:1. The primary outcome is the success rate of splenic vessel-preserving (Kimura) approach. The secondary outcomes include total success rate of spleen preserving (Kimura and Warshaw approaches), intraoperative variables, time to functional recovery, postoperative complications, mortality, and cost/efficacy analysis.
Discussion
We plan to conduct a randomized controlled trial to detect the potential advantages of robotic approach in spleen vessels preservation compared with traditional laparoscopic approach. RSPDP may improve spleen vessels preservation rate in selected patients.
Trial registration
Chinese Clinical Trial Registry, No: ChiCTR2000029177. Registered on 18 January, 2020.
Figure 1