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
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
Posted 28 Sep, 2020
On 05 Jan, 2021
Received 18 Dec, 2020
Received 12 Dec, 2020
Received 12 Dec, 2020
Received 11 Dec, 2020
Received 09 Dec, 2020
On 01 Dec, 2020
On 30 Nov, 2020
On 28 Nov, 2020
On 28 Nov, 2020
On 28 Nov, 2020
Invitations sent on 07 Nov, 2020
On 05 Nov, 2020
On 24 Sep, 2020
On 22 Jul, 2020
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
Posted 28 Sep, 2020
On 05 Jan, 2021
Received 18 Dec, 2020
Received 12 Dec, 2020
Received 12 Dec, 2020
Received 11 Dec, 2020
Received 09 Dec, 2020
On 01 Dec, 2020
On 30 Nov, 2020
On 28 Nov, 2020
On 28 Nov, 2020
On 28 Nov, 2020
Invitations sent on 07 Nov, 2020
On 05 Nov, 2020
On 24 Sep, 2020
On 22 Jul, 2020
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