Here is the design of a clinical trial:

Official Title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial

Included conditions:
- Pancreatic Carcinoma
- Laparoscopic
- Pancreaticoduodenectomy

Study Armgroups:
- {'label': 'TLPD', 'type': 'EXPERIMENTAL', 'description': 'Total laparoscopic pancreaticoduodenectomy for pancreatic cancer', 'interventionNames': ['Procedure: TLPD Surgery']}
- {'label': 'OPD', 'type': 'EXPERIMENTAL', 'description': 'Open pancreaticoduodenectomy for pancreatic cancer', 'interventionNames': ['Procedure: OPD Surgery']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'TLPD Surgery', 'description': 'TLPD', 'armGroupLabels': ['TLPD']}
- {'type': 'PROCEDURE', 'name': 'OPD Surgery', 'description': 'OPD', 'armGroupLabels': ['OPD']}

Primary Outcomes:
- {'measure': '5-year overall survival', 'description': '5-year overall survival', 'timeFrame': '5 year'}

Please estimate the sample size based on the assumption: 
One-tailed significance level of 2.5%, power of 80%, and a balanced design (1:1 ratio). The maximum conversion rate from LPD to OPD is assumed to be 10%. An additional 10% of patients are considered for non-resectable patients, withdrawals, and loss to follow-up.
Sample size
        The sample size calculation was performed according to the primary endpoint, the 5-year OS rate, and the non-inferiority design of this trial. Assumptions were made based on a previous study by Kuesters et al,25 which compared LPD with OPD for PDAC treatment with the 5-year OS rate being 20% in the LPD group and 14% in the OPD group. Based on the 6% decrease in 5-year OS rate in the OPD group compared with the LPD group, the sample size required for each group was estimated to be 86 patients to achieve a non-inferiority limit of 10% at a one-tailed significance level of 2.5% with a power of 80% and a balanced design (1:1 ratio). Moreover, the primary analyses will be based on the modified intention-to-treat (mITT), per-protocol (PP) and as-treated (AT) sets. We aimed to reach a statistical power of 80% when analysing the smallest population, namely the PP set.
        Patients converted from LPD to open surgery will not be included in the PP set. Patients will be randomised in a 1:1 manner to either the LPD or OPD arm, with the maximum conversion rate from LPD to OPD assumed to be 10%, resulting in a ratio of up to 9:10 in the PP set. To meet these assumptions, 83 patients in the LPD group and 91 patients in the OPD group will be needed for analysis using the one-sided t test at a one-sided significance level of 0.025. PASS V.15.0.5 will be used for the calculations. An additional 10% of patients will be needed to be randomised considering the non-resectable patients, patients withdrawing from the study, and patients lost to follow-up. Accordingly, 100 patients in the LPD arm and 91 patients in the OPD arm will be randomised. The randomisation ratio of this trial is 1:1, requiring 100 patients in each arm and 200 patients in total to be included for randomisation.