Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study

Abstract

Background Data from interventional studies suggest that a peritoneal flap after pelvic lymph node dissection (LND) during laparoscopic, robotic-assisted radical prostatectomy (RARP) may reduce the rate of symptomatic lymphoceles in transperitoneal approach. However, most of these studies are not conducted in a randomized controlled fashion, thus limiting their scientific value. A recent prospective, randomized, controlled trial (RCT) did not show superiority of a peritoneal flap while further trials are lacking. Therefore, the aim of the presented RCT will be to show that creating a peritoneal flap decreases the rate of symptomatic lymphoceles compared to the current standard procedure without creation of a flap. Methods/design PELYCAN is a parallel-group, patient- and assessor-blinded, phase III, adaptive randomized controlled superiority trial. Men with histologically confirmed prostate cancer who undergo transperitoneal RARP with pelvic LND will be randomly assigned in a 1:1 ratio to two groups—either with creating a peritoneal flap (PELYCAN) or without creating a peritoneal flap (control). Sample size calculation yielded a sample size of 300 with a planned interim analysis after 120 patients, which will be performed by an independent statistician. This provides a possibility for early stopping or sample size recalculation. Patients will be stratified for contributing factors for the development of postoperative lymphoceles. The primary outcome measure will be the rate of symptomatic lymphoceles in both groups within 6 months postoperatively. Patients and assessors will be blinded for the intervention until the end of the follow-up period of 6 months. The surgeon will be informed about the randomization result after performance of vesicourethral anastomosis. Secondary outcome measures include asymptomatic lymphoceles at the time of discharge and within 6 months of follow-up, postoperative complications, mortality, re-admission rate, and quality of life assessed by the EORTC QLQ-C30 questionnaire. Discussion The PELYCAN study is designed to assess whether the application of a peritoneal flap during RARP reduces the rate of symptomatic lymphoceles, as compared with the standard operation technique. In case of superiority of the intervention, this peritoneal flap may be suggested as a new standard of care. Trial registration German Clinical Trials Register DRKS00016794. Registered on 14 May 2019.

Peritoneal Distraction Technique to Reduce Symptomatic Lymphoceles after Retzius-Sparing Robot-Assisted Radical Prostatectomy

“…Both authors reported a reduction in the incidence of symptomatic lymphocele formation with the use of their techniques. [ 10 13 ] However, Brundl et al . performed a randomized controlled trial to study the efficacy of Lebeis’ technique in patients undergoing conventional RARP and did not find any significant difference in the lymphocele incidence.…”

“…[ 6 7 8 9 ] Among these, the use of peritoneal flaps have emerged as a promising novel technique to tackle this complication. [ 10 11 12 13 ] However, there is sparse literature on the use of this technique in Retzius-sparing RARP. Therefore, we developed a peritoneal distraction technique and aimed to assess its impact on lymphocele formation in Retzius-sparing RARP group.…”

The role and controversy of pelvic lymph node dissection in prostate cancer treatment: a focused review

“…Based on the available literature, the likelihood of lymphocysts following PLND varies between 1.3% and 25% [38][39][40], and their presence is not solely attributed to the enlargement of PLND excision [38,41], but also to advanced age, elevated BMI (Body Mass Index), and a past occurrence of peripheral vascular/lymphatic lesions [41][42][43][44]. To reduce the number of lymphocysts, preventive measures such as constructing a peritoneal flap [45,46]、peritoneal opening [47,48], elastic clamping of lymphatic vessels [39], bipolar electrocoagulation of the trauma, and spraying of haemostatic powder [49] can be taken during operation. Nevertheless, lymphocysts do not consistently manifest symptoms, and interventions are typically limited to symptomatic lymphocysts (such as excessive abdominal-pelvic effusion or secondary infections).…”

Peritoneal interposition flap reduces symptomatic lymphocele following transperitoneal robot-assisted radical prostatectomy and pelvic lymph node dissection: An updated meta-analysis

“…In the future, the results of another ongoing RCT (Pelycan) should clarify the benefits of PIF in preventing SLC. [40]…”