Here is the design of a clinical trial:

Official Title: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)

Included conditions:
- Disease of Pancreatic or Periampullary Lesions

Study Armgroups:
- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual.'}
- {'label': 'PGA felt reinforcement', 'type': 'ACTIVE_COMPARATOR', 'description': 'In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.', 'interventionNames': ['Drug: PGA felt reinforcement']}

Interventions:
- {'type': 'DRUG', 'name': 'PGA felt reinforcement', 'description': 'During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil®, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.', 'armGroupLabels': ['PGA felt reinforcement']}

Primary Outcomes:
- {'measure': 'Incidence of a clinically relevant POPF (ISGPS grade B/C)', 'description': 'Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF', 'timeFrame': 'within 3 months after surgery'}

Please estimate the sample size based on the assumption: 
The significance level is set at α = 0.05 (two-sided) with a power of more than 80%. Approximately 10% of patients are expected to be ineligible for surgery.
Sample size estimation
        This trial was designed to evaluate the efficacy of group A compared with group B in terms of the incidence of POPF. In cases using PGA felt at the pancreaticojejunostomy in partial pancreatoduodenectomy with an MPD diameter of 3âmm or less, the incidence of POPF was 15.5% [18, 19]. The incidence of POPF was 26% in a previous report without PGA felt at the pancreaticojejunostomy in partial pancreatoduodenectomy with an MPD diameter of 3âmm or less [29]. When statistical analysis is performed for a significance level of Î±â=â0.05 (two-sided) in a superiority design, 231 patients are calculated to be required per arm, with a power 100(1Â âÂ Î²) of more than 80%, under the assumption that a small number of patients may be deemed ineligible and may thus be excluded from the analysis. Furthermore, as approximately 10% of the patients are expected to be ineligible for surgery, the sample size was eventually increased to 514 patients (257 patients per arm). This sample size was calculated using software PASS 15.0.6.
        In the evaluation of the secondary endpoints, a hypothesis test will be used for comparison between both groups, although formal power calculations for these analyses have not been performed.